MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOCLASSIC SL STEM 4 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); No Information (3190)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received per and x-rays for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to unknown reasons.
Additional Manufacturer Narrative
Additional information which was received on dec 4, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents 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
Patient was implanted on an unknown side and underwent revision surgery due to lysis.
Additional Manufacturer Narrative
Event description: it was reported that the patient was implanted with a metasul liner, metasul head and an alloclassic stem on (b)(6)2005 and underwent revision on (b)(6)2020 due to lysis.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 undated ap radiograph and one lateral image have been received.The images demonstrate a right total hip arthroplasty.There is a pronounced area of lysis in the lower third of the femoral stem and a prominent seam laterally along the stem.Patient data: k.S., male, born (b)(6)1930, 171 cm, 87 kg no additional medical records were provided; therefore, the detailed sequence of events remains unknown.Product evaluation: no product was returned due to hospital policy; therefore, visual and dimensional evaluation 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.Conclusion: it was reported that the patient was implanted with a metasul liner, metasul head and an alloclassic stem on (b)(6)2005 and underwent revision on (b)(6)2020 due to lysis.Based on the radiograph provided, the reported lysis can be confirmed.Nevertheless, there are no images showing the anatomy of the patient before implantation; therefore, potential osseous changes during the time in vivo cannot be assessed.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 available data, the exact course and cause of the lysis is unknown.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.

• Brand Name: ALLOCLASSIC SL STEM 4 12/14
• Common Device Name: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10959545
• Report Number: 0009613350-2020-00570
• Device Sequence Number: 19705458
• Product Code: LZO
• UDI-Device Identifier: 00889024481121
• UDI-Public: 00889024481121
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/15/2009
• Device Model Number: N/A
• Device Catalogue Number: 2844
• Device Lot Number: 2221474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 07/06/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/17/2020; 07/26/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 87