MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED 18/225, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.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.(b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to implant fracture.
Event or Problem Description
No event update.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, g4, g7, h10.Part specific investigation: there was no similar investigated event within the last 1 month and there was no similar investigated events within the last 6 months prior to the event date found for this item number.Result: issue evaluation request is not required.Lot specific investigation: unknown: lot number is not available.Result: issue evaluation request is not required.Dhr review: as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Review of event description: event summary: it was reported that a wagner revison stem was implanted in 2005 and revised on (b)(6) 2019 due to implant fracture.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Product compatibility couldn't be performed since only one item number is available.Dhr review: dhr review couldn't be performed since lot# is unavailable.Conclusion summary: it was reported that a wagner revison stem was implanted in 2005 and revised on (b)(6) 2019 due to implant fracture.In vivo time of the device is 14 years.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED 18/225, TAPER 12/14
• Common Device Name: WAGNER SL REVISION HIP STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9197106
• Report Number: 0009613350-2019-00621
• Device Sequence Number: 16245622
• Product Code: LZO
• UDI-Device Identifier: 00889024485235
• UDI-Public: 00889024485235
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K043356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.218
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention