MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/3, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: biolox delta, ceramic femoral head, xl, 36/+7, taper 12/14; item#: 00877503604; lot#: 3005266.Bone screw self-tapping 6.5 mm dia.25 mm length; item#: 00625006525; lot#: 63010466.Bone screw self-tapping 6.5 mm dia.25 mm length; item#: 00625006525; lot#: 63010465.Unknown cup; item#unknown; lot#unknown.Therapy date: unknown.The manufacturer did not receive x-rays for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 or Problem Description
Patient was implanted on the right side and underwent revision due to periprosthetic fracture.
Additional Manufacturer Narrative
Additional information was received on jan 19, 2021.The manufacturer received x-rays, other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision due to periprosthetic fracture.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
Event description: it was reported that the patient underwent primary right total hip arthroplasty.Subsequently, when the patient was walking with the physical therapist, they heard a cracking sound.Radiographic evaluation showed a periprosthetic fracture and subsidence of the femoral shaft, which was revised on the same day.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.Medwatch report (b)(4): the patient underwent a primary right total hip arthroplasty without complication.The patient did well in the recovery room and was transferred to the floor.Patient was walking with physical therapy without difficulty when there was an audible crack and the right leg shortened.Patient was placed back in bed without significant pain.The x-ray revealed a periprosthetic fracture with displacement of a medial calcar fragment and significant subsidence of the stem.The hip remained located.I suspect that there is a small calcar crack that was not visible at the time of the primary stem placement.Because of the significant amount of subsidence, i recommended that we proceed back to the operating thereafter for revision of the femoral stem and fixation of the fracture fragment same day as original surgery.- patient data: female, 70 years of age (at date of event), 160 cm, 70 kg, bmi: 26.5 medical history: allergies, hypertension, morbidly obese no medical data such as radiographs or surgical reports were provided for evaluation.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 could not be performed as not all involved devices are known.The compatibility check of the known devices 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.Conclusion: it was reported that the patient underwent primary right total hip arthroplasty.Subsequently, when the patient was walking with the physical therapist, they heard a cracking sound.Radiographic evaluation showed a periprosthetic fracture and subsidence of the femoral shaft, which was revised on the same day.According to the medwatch report, the surgeon suspects that there was a small calcar crack that was not visible at the time of the primary surgery, leading to the bone fracture and the stem subsidence.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).Due to the lack of medical records, the reported event could not be assessed and therefore the reported event cannot be verified (confirmed).According to the description, it can be assumed that a fissure or calcar crack occurred during implantation, which led to the postoperative bone fracture and the stem subsidence.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 or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
Additional information which was received on aug 11, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received device for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
Investigation results updated; product examination added.
Additional Manufacturer Narrative
1.Event description: it was reported that the patient underwent primary right total hip arthroplasty.Subsequently, when the patient was walking with the physical therapist, they heard a cracking sound.Radiographic evaluation showed a periprosthetic fracture and subsidence of the femoral shaft, which was revised on the same day.Harm: s3 - bone fracture hazardous situation: bone is incorrectly prepared for implantation and not corrected before completing implantation.2.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.Medwatch report (b)(4): the patient underwent a primary right total hip arthroplasty without complication.The patient did well in the recovery room and was transferred to the floor.Patient was walking with physical therapy without difficulty when there was an audible crack and the right leg shortened.Patient was placed back in bed without significant pain.The x-ray revealed a periprosthetic fracture with displacement of a medial calcar fragment and significant subsidence of the stem.The hip remained located.I suspect that there is a small calcar crack that was not visible at the time of the primary stem placement.Because of the significant amount of subsidence, i recommended that we proceed back to the operating thereafter for revision of the femoral stem and fixation of the fracture fragment same day as original surgery.Patient data: female, 70 years of age (at date of event), 160 cm, 70 kg, bmi: 26.5.Medical history: allergies, hypertension, morbidly obese.No medical data such as radiographs or surgical reports were provided for evaluation.3.Product evaluation: the fitmore stem and the biolox head were returned for examination.The biolox head has countless point-like metal smears distributed over the entire surface.There is also a long strip of metal smearing running from the taper marking on the rim towards the pole, most likely from dislocating the head during revision surgery.Further, the head taper has metal smears from being seated on the stem taper.The fitmore stem has some scratches on its surface.In addition, there are scratches in the direction of the stem axis on the medial side of the taper, most likely deriving from removal of the biolox head, and a worn area on the medial side of the stem just proximal to the ti-vps coating.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as not all involved devices are known.The compatibility check of the known devices 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.5.Conclusion: it was reported that the patient underwent primary right total hip arthroplasty.Subsequently, when the patient was walking with the physical therapist, they heard a cracking sound.Radiographic evaluation showed a periprosthetic fracture and subsidence of the femoral shaft, which was revised on the same day.According to the medwatch report, the surgeon suspects that there was a small calcar crack that was not visible at the time of the primary surgery, leading to the bone fracture and the stem subsidence.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).Due to the lack of medical records, the reported event could not be assessed and therefore the reported event cannot be verified (confirmed).According to the description, it can be assumed that a fissure or calcar crack occurred during implantation, which led to the postoperative bone fracture and the stem subsidence.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).

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/3, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9835413
• Report Number: 0009613350-2020-00123
• Device Sequence Number: 1212824
• Product Code: KWA
• UDI-Device Identifier: 00889024482876
• UDI-Public: 00889024482876
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K071723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.303
• Device Lot Number: 2989040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 07/06/2021; 08/11/2021; 10/20/2021
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 02/03/2021; 07/06/2021; 09/09/2021; 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70