MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX HEAD

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Failure of Implant (1924)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Medical product: durasul, alpha insert, ii/32; catalog no#: 01.00013.409; lot#: 2436740.Therapy date: (b)(6) 2020.The manufacturer did receive user report, implantation report and revision report for review.As no lot number was provided, the device history records could not be reviewed.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Product was implanted on an unknown date and implant has fractured into multiple fragments.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient had an initial left total hip arthroplasty on (b)(6) 2008.After more than 12 years in vivo, on (b)(6) 2020, the femoral head fractured and the patient was revised on (b)(6) 2020.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: in total 5 radiographs were received and assessed by a health care professional (radiologist).Summary of imaging: ap and frog lateral left hip dated (b)(6) 2008.Ap left hip dated (b)(6) 2008.Ap and frog lateral left hip dated (b)(6) 2020.Images dated (b)(6) 2008 and (b)(6) 2008 demonstrate anatomic alignment of the left hip arthroplasty without complication.Images dated (b)(6) 2020 demonstrate interval fracture of the ceramic head of the left hip femoral implant with proximal migration of the femur.Ossific fragments are noted near the greater trochanter and appear chronic.The acetabular cup abduction angle measures 42 degrees.There is no evidence of loosening, wear or abnormal radiolucency.Surgical report: surgical report from (b)(6) 2020: diagnosis: fracture of total htep, arterial hypertension treatment: revision: replacement of acetabular insert and replacement of left head, open removal of periarticular ossifications at left hip joint components: zimmer biomet durasul ii/32, merete bioball 12/14 adaptor m neutral, delta head 32mm description of procedure: anterolateral approach.Access the joint and remove the anterocranial heterotrophic ossification.After opening the joint capsule, visible ceramic particles and metallotic interface.After removal of the largest ceramic particles, dislocation of the artificial joint.Removal of the head fragments and irrigation with 3 liters of nacl solution.Removal of the scratched but otherwise intact insert.Insertion of the new components, reduction and closure.Surgical report from (b)(6) 2008: diagnosis: coxarthrosis bilaterally, more pronounced on the left, with osteophytes, flexion contracture, chronic synovitis, cysts in the area of the acetabular roof treatment: femoral neck osteotomy, removal of osteophytes, synovectomy, spongiosaplasty, placement of allofit cementless shell 52, durasul insert, avenir stem 5, short neck, muscle lengthening at flexors.Description of procedure: minimalinvasive access according to ocm.Display of larger osteophytes that limit the motion and increase the risk of luxation.Removal of the osteophytes.Total synovectomy.Spongiosaplasty at the acetabular roof.Insertion of all components.Reposition.Closure.Patient data: u.S., female, born (b)(6) 1945.Product evaluation: visual examination: the sulox head and durasul alpha insert were returned for examination.The sulox head was returned in 10 fragments and is labeled on the outer surface with 08 os 3271 32s/-3.5.Parts of the head taper can be seen on the three largest fracture fragments.In particular, there are blackish metal smears on the bottom of the head taper.Metal smears are also found on the fracture surfaces, indicating that these occurred after the fracture.Brownish material can be seen on the sides of the head taper, which is likely organic deposits.Further, the head's taper does not show the commonly observed seating pattern that would indicate a proper seating of the head on the stem.The durasul alpha insert shows a yellowish discoloration.On the outer surface, the two impressions from the shell pins can be seen evenly distributed on both sides of the intact pole peg, indicating the correct placement of the insert in the shell.Otherwise, some scratches and indentations can be seen on the outer surface and on the outer rim (snap connection), which can be attributed to the revision surgery.The articulation surface is roughened and has countless scratches, nicks, and inclusions of small sulox particles originating from the fractured head.The rim also has scratches and nicks as well as a sheared chip.The stem remained implanted; therefore, an examination of the stem taper could not be performed.Review of product documentation: device purpose: all involved devices are 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 of the sulox head and the durasul alpha insert.Raw material certificate: the raw material certificate of the sulox head documents the chemical, physical and mechanical analysis of the raw material.All material properties comply with the specifications.Conclusion: it was reported that the patient had an initial left total hip arthroplasty on (b)(6) 2008.After more than 12 years in vivo, on (b)(6) 2020, the femoral head fractured and the patient was revised on (b)(6) 2020.The provided radiographs demonstrate an anatomic alignment of the left hip following implantation in 2008 and an interval fracture of the ceramic head in 2020.No additional follow up radiographs between 2008 and 2020 have been received.The blackish metal smearing found on the bottom of the head taper during visual examination indicates that the stem taper was in direct contact with the bottom of the head taper.On the radiograph from (b)(6) 2008 a small gap between the stem taper and the bottom of the head taper is still visible, while on the radiographs taken after the head fracture, the fracture fragments are already dislocated out of the acetabular insert.Therefore, it remains unknown, if the stem taper was in contact with the bottom of the head taper before or after the head fracture.Further, the head's taper does not show the commonly observed seating.Therefore, it remains unknown if the head was properly seated on the stem.If and to what extend this may have contributed to the fracture remains unknown the revision report confirms the findings of the radiographs and the visual examination.The implantation report from 2008 was reviewed with no anomalies noted.The raw material certificate of the sulox head demonstrates the correct chemical, physical and mechanical properties.Further, the dhr was reviewed with no anomalies noted.Therefore, 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).Based on the investigation the reported head fracture can be confirmed; nevertheless, an exact root cause could not be found.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.

• Brand Name: SULOX HEAD
• Type of Device: SULOX HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11003601
• MDR Text Key: 221296680
• Report Number: 0009613350-2020-00579
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization