MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 20/225; WAGNER HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 osseoti multihole 56mm f - item# 10010266 lot# 66535941.Bone screw 6.5x35 self-tap - item# 00625006535 lot# j7667940.Bone screw 6.5x30 self-tap - item# 00625006530 lot# 66187530.Bone screw 6.5x25 self-tap - item# 00625006525 lot# 66134219.G7 vit e frdm const lnr 36mm f - item# 30203606 lot# 66509403.12/14 cocr frdm 36mm x -3 - item# 802403602 lot# 3036579.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had a revision surgery approximately 1 year after implantation, during the procedure a femoral fracture was found while implanting the final implants.Cerclage wire was placed around the fracture.Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records and timeline identified the following: during a clinical visit prior revision, the following was noted: left hip pain for 1 year, reports hip keeps popping out of place, wears an abduction brace.Able to walk for 5-10 minutes without pain.5 dislocations since hip replacement.Failure of ingrowth left femoral stem with subsidence, no fracture, pedestal and peripheral radiolucency femoral component.Diagnosis: femoral neck and head removed with difficulty.Portion of greater trochanter removed to avoid fracture.No bone noted on femoral component acetabular liner and 2 screws removed, felt the acetabular component was slightly retroverted therefore it was explanted.During revision, trial component and reamings had no issues with the bone however posterior and including the lesser trochanter there was a fracture noted and this not extend beyond the level of the lesser trochanter.This was done due to the size of the femoral component which is larger than the trial component.Based on the medical records, the complaint is confirmed.A definitive root cause cannot be determined.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 or Problem Description
No additional event information at this time.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 20/225
• Common Device Name: WAGNER HIP PROTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 19691162
• Report Number: 0009613350-2024-00281
• Device Sequence Number: 20642937
• Product Code: LZO
• UDI-Device Identifier: 00889024593374
• UDI-Public: (01)00889024593374(17)271221(10)3137353
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K191781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0100102220
• Device Lot Number: 3137353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 66 KG