MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX HEAD, M¸ 32/0, TAPER 12/14; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Biocompatibility (2886); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Anemia (1706); Failure of Implant (1924); Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 07/25/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states the manufacturer did not receive x-rays for review.The manufacturer received other documents which will be reviewed as part of ongoing investigation.Lot numbers were received and the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient underwent total hip arthroplasty on an unknown date.Since (b)(6) 2021 patient started experiencing pain and cracking noises while walking.X-ray imaging showed fracture of the ceramic head.No trauma has been reported.

Event Description

Investigation results are now available.

Manufacturer Narrative

D10 concomitant medical products: durasul, alpha insert, nn/32 ref: 0100013414; lot: 2998890.Allofit alloclassic shl 62/nn ref: 00000004250; lot: 3017597.Avenir müller, stem, standard, uncemented, ha, 8, taper 12/14 ref: 0106010008; lot: 2995764.Therapy date (b)(6) 2021.Investigation results were made available.1.Event description: it was reported that the patient underwent right total hip arthroplasty on the (b)(6), 2020 and since (b)(6), 2021 started experiencing pain and cracking noises when walking.X-ray imaging performed showed a fracture of the ceramic head.A revision surgery was performed on (b)(6), 2021 with a revision of the liner and femoral head.No trauma event was reported which could have potentially caused or contributed to the reported event.Harm: s3 - non-functioning joint hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: due diligence: no furtherdue diligence required as all required information to support the conclusion is available or was already requested.X-rays: one postoperative ap x-ray dated (b)(6), 2020 was received.Two preoperative ap x-rays dated (b)(6) 2021 were received, whereby a fracture of the femoral head can be seen.Additionally, both preoperative x-rays were reviewed by radiologists (external hcp - mmi group), whereby the following assessment was made: two views of the right hip demonstrate a right total hip arthroplasty with cement fixation of the acetabular cup.Evidence of a fractured femoral head.No radiolucency.Images: four images were received showing the implant labels of the femoral head, liner, cup and stem.A bfarm user report as well as an updated user report were received.Contrary to what has been stated in the report, no copies of the implantation or revision report have been received.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.5.Conclusion: it was reported that the patient underwent right total hip arthroplasty on the (b)(6) 2020 and since (b)(6) 2021 started experiencing pain and cracking noises when walking.X-ray imaging performed showed a fracture of the ceramic head.A revision surgery was performed on (b)(6) 2021 with a revision of the liner and femoral head.No trauma event was reported which could have potentially caused or contributed to the reported event.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).No product nor pictures of the explanted products were received.Neither visual nor dimensional evaluation could therefore be performed.The condition of the femoral head and associated parts is therefore unknown.Additionally, no clinical reports were received.However, based on the received x-rays the reported event can be confirmed.Potential contributing conditions such as patient factors that may have affected the performance of the components such as bmi, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the reported event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

Event description: it was reported that the patient underwent right total hip arthroplasty on the april 30, 2020 and since jul 25, 2021 started experiencing pain and cracking noises when walking.X-ray imaging performed showed a fracture of the ceramic head.A revision surgery was performed on jul 30, 2021 with a revision of the liner and femoral head.No trauma event was reported which could have potentially caused or contributed to the reported event.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: one postoperative ap x-ray dated may 4, 2020 was received.Two preoperative ap x-rays dated jul 26, 2021 were received, whereby a fracture of the femoral head can be seen.Additionally, both preoperative x-rays were reviewed by radiologists (external hcp - mmi group), whereby the following assessment was made: two views of the right hip demonstrate a right total hip arthroplasty with cement fixation of the acetabular cup.Evidence of a fractured femoral head.No radiolucency.Four mri images with contrast dated feb 12, 2019 as well as three intraoperative fluoroscopy images dated apr 30, 2020 were received as part of the additional information received on jan 18, 2022 (addi396197).However, these images are not of much merit to the investigation.With one of the fluoroscopy images, it seems on the picture that the head is currently placed on the stem.However, additional x-rays with additional views would be necessary for a better assessment.Images: four images were received showing the implant labels of the femoral head, liner, cup and stem.Additionally, one postoperative image of the fractured sulox head was received.No further images of the components were received.An additional image of the fractured femoral head as well as the retrieved fragments was received.The ceramic head is fractured into several pieces.Based on the picture it cannot be evaluated if some pieces are missing or if the head is complete.The articulation surfaces as well as the fracture surfaces show several metallic smearing.The visible parts of the head's taper does not show the commonly observed seating pattern.The commonly observed seating pattern could indicate a proper seating on the head.Based on the available pictures this cannot be evaluated.The reported event of the fracture can be confirmed based on the received pictures.Patient data: (b)(6), 1959, male, 87kg, 186cm, bmi 25.1.Implant pass received with the labels of the devices implanted in the initial surgery dated april 30, 2020 and the devices implanted in the revision surgery dated (b)(6) 2021.A bfarm user report as well as an updated user report were received.Contrary to what has been stated in the report, no copies of the implantation or revision report have been received.Surgical report for implantation dated apr 30, 2020 surgeon: (b)(6).Indication: right coxarthrosis, large bone defect, extensive osteophytes.Procedure: tha minimally invasive, osteoplasty, ablation of osteophytes findings: extensive cartilage defect extending to the bone at the head and acetabulum.Large osteophytes radiologically visible osteophytes at the acetabulum.Filling of a caudal acetabular defect and several previously carefully cleared cysts with bone from the femoral head and insertion of the allofit cup, which clamps stably to the acetabular base.Insertion of the closure screw and insertion of the inlay, which also clamps stably.Removal of the large osteophytes, which impair the mobility of the hip joint.Injection of a total of 50 ml naropin 0.2 % with 1 suprarenin into the capsular tissue for pain control and bleeding prophylaxis around the proximal femur.Positioning of the original head, after previously inserting bone has been placed in defects at the entrance to the prosthesis stem.The result is a new functionally stable hip joint with largely balanced leg length.Irrigation and final inspection of the joint.Fascia suture.Injection of 50 ml naropin 0.2 % with 1 suprarenin intra-articularly into the joint for pain control and bleeding prophylaxis.A total of 3 radiographs are taken (hip a.P.And proximal femur target image of the shaft tip; bv control, printout) are taken.Difficult surgery due to voluminous musculature.Surgical report for revision surgery dated jul 30, 2021 surgeon for revision surgery: (b)(6).Indication: the patient spontaneously felt a crack in the right hip joint without trauma.He continued to walk for 5 days with considerably reduced activity.Procedure: head and inlay replacement, removal of multiple large and small ceramic head particles, synovectomy, chiseling away of ossifications.Findings: moderate metallosis discovered intraoperatively.The taper and neck of the prosthesis is somewhat altered and duller than normal, probably due to metal wear by the ceramic particles.Overall, stem portion is still well intact.A complete synovectomy is performed due to metallosis and tiny ceramic particles.Extensive irrigation, several more ceramic particles are also obtained with jet lavage.Some ossifications ventral to the acetabulum are chiseled away to ensure normal mobility of the new hip joint.Injection of 50 ml of the mixture of ropivacain + epinephrine into the soft tissue around the proximal femur.Injection of 50 ml of tranexamic acid intra-articularly.Postoperative radiology shows good placement.Doctor letter dated jan 15, 2020.No additional findings/notes other than those stated in the doctor¿s letter dated apr 29, 2020.Doctor letter dated apr 29, 2020.Diagnosis: right coxarthrosis.Anamnesis: pain for longer than 1 year.Findings: mri from feb.2019 shows a cranial completely depleted joint space and significant bone edema in the bone near the joint.Signs of extensive cam impingement.Therapy recommendation: total hip replacement on may 28, 2020.Doctor letter dated may 4, 2020.Diagnosis: right coxarthrosis.Secondary diagnosis: postoperative blood loss anemia ¿ no transfusion required therapy: implantation of a cementless right total hip endoprosthesis with minimal invasive technique on apr 30, 2020.Anamnesis: the patient was admitted because of increasing, severe, load-dependent hip joint pain on the right side and a significant limitation of movement.The radiograph of the pelvis and the x-ray of the axial hip joint axial showed advanced coxarthrosis on the right.Course: after the usual preoperative preparation, we performed the above procedure on apr 30, 2020.The intra- and postoperative course was without complications.The postoperative mobilization took place under load after pain moderation.Wound healing was per primam and at discharge the wound was free of irritation.Doctor letter dated jul 26, 2021.Diagnosis: right ceramic femoral head fracture anamnesis: since yesterday, sudden onset of pain in the right hip joint, with cracking noises when moving, which was which were not there before.No fall remembered.Physical examination: distinct joint rubbing in the re hip joint during active or passive motion testing.Findings: pelvic overview image (lauenstein) right hip jul 26, 2021, correct implant fit right total hip with fractured ceramic head.Therapy recommendation: immediate revision with head+ inlay change recommended.Inlay alofit 63, 32-m sulox head.Doctor letter dated aug 4, 2021.Primary diagnosis from surgery on jul 30, 2021: fracture of ceramic femoral head after implantation right tha on apr 30, 2020.Secondary diagnosis from surgery on jul 30, 2021: postoperative blood loss anemia - not requiring transfusion.Therapy: removal of multiple large and small ceramic head particles, synovectomy, right femoral head and inlay change (jul 30, 2021) new implants: biolox option head m, 36mm, durasul inlay, 36mm microbiology: no signs of infection anamnesis: patient presented himself on jul 26, 2021.No complication since implantation on apr 30, 2020.A fall event did not precede the event of fracture.Procedure: revision performed on jul 30, 2021 without and intra- or postoperative complications.The postoperative mobilization took place under pain-adapted weight-bearing of the operated leg.Wound healing was per primam.At discharge, the wound was free of irritation.There was no evidence of bacteria in the tissue samples taken intraoperatively.With a wells score <2, there was no evidence of deep vein thrombosis.Mri findings report dated feb 12, 2019.Right coxarthrosis with cam impingement.Four images of the right pelvis contained within the report.Radiological findings report dated apr 29, 2020.Indication: x-ray pelvic overview lying down, deeply adjusted + measuring ball, performed on 29.04.2020.X-ray hip joint according to lauenstein right, performed on 29.04.2020.Assessment: advanced coxarthrosis on the right with sclerosis of the articular surfaces, joint space reduction and osteophytic attachments.Moderate coxarthrosis on the left.Co-occluded measuring body.Radiological findings report dated may 4, 2020.Indication: x-ray pelvis overview postop, performed on 04.05.2020.Assessment: axially correct joint position after right hip tep implantation.No periprosthetic fracture.The angle of inclination is 35°.Moderate coxarthrosis on the left.Skin staple suture on the right.Additional radiological findings report dated may 4, 2020.Indication: x-ray hip joint a.P.Right, performed on 04.05.2020.Assessment: postoperative examination after hip arthroplasty on the right side with implantation of a cementless tep because of coxarthrosis.Correct position of the spherical allofit cup on the pelvis in the a.-p.Radiographic path or conclusive fit of the prosthesis stem in the femoral medullary cavity.Inclination angle of the prosthetic cup 39°.Perfect articulation in both hip joints.Regular bone structure radiological findings report dated aug 1, 2021.Irritation-free fit of the non-cemented hip tep.The right inclination angle is approx.39 °.Perfect articulation in both hip joints with advanced coxarthrosis on the left.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the patient underwent right total hip arthroplasty on the april 30, 2020 and since july 25, 2021 started experiencing pain and cracking noises when walking.X-ray imaging performed showed a fracture of the ceramic head.A revision surgery was performed on jul 30, 2021 with a revision of the liner and femoral head.No trauma event was reported which could have potentially caused or contributed to the reported event.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Radiological images were provided dated may 4, 2020 and july 26, 2021 showing an appropriate seating of the femoral head in the former image and a fractured femoral head in the latter image.However, no radiological images directly post-implantation or throughout the continuum of care leading up to the fracture event on july 25, 2021 were received.Pictures of the explanted and fractured femoral head along with its fragments were received.The ceramic head is fractured into several pieces.Based on the picture it cannot be evaluated if some pieces are missing or if the head is complete.The articulation surfaces as well as the fracture surfaces show several metallic smearing.The visible parts of the head's taper does not show the commonly observed seating pattern.The commonly observed seating pattern could indicate a proper seating on the head.Based on the available pictures this cannot be evaluated.The receipt of the explanted femoral head would assist in the assessment of the seating pattern, however, no products were received for examination.The reported event of the fracture can be confirmed based on the received pictures and radiological images.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the reported event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Two preoperative x-rays dated (b)(6) 2020, received showing coxarthrosis of the right hip.Patient medical history received and reviewed by an hcp.No valuable information was found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

It was reported that patient underwent revision of right total hip implant due to experiencing a sudden painful cracking sensation in the joint without any trauma preceding the event approximately 15 months after initial surgery.During revision, the ceramic head was found fractured in multiple small and large fragments throughout the joint with moderate metallosis noted.A complete synovectomy was performed to remove the tissue and fragments.Some ossifications were debrided from around the acetabular shell, and some wear was noted on the cone and neck.The stem and shell remained intact, and the head and liner were replaced without complications.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SULOX HEAD, M¸ 32/0, TAPER 12/14
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12407188
• MDR Text Key: 269361968
• Report Number: 0009613350-2021-00451
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024416987
• UDI-Public: (01)00889024416987(17)291031(10)3011899
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 17.32.06
• Device Lot Number: 3011899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 04/24/2022; 10/07/2022; 06/14/2023
• Supplement Dates FDA Received: 11/17/2021; 04/28/2022; 10/13/2022; 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 87 KG