MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	01.06010.004
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial tha, the surgeon experienced difficulty fitting the implant.The surgeon noticed that the stem implant did not seat correctly after rasping.Additionally, the surgeon experienced difficulties trying to extract the stem.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Report source - foreign : canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.The complained product was returned for examination.There are very apparent signs of manipulation in the form of dents (repeated impact marks), scratches, especially on and around the neck and taper, evident on the device.A dimensional analysis was performed: a representative feature of the device (total length) was taken to confirm the dimensional conformity.The total length of the device could be determined to be conforming to the specifications.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.Review of the device manufacturing records for the returned product was performed: at the moment of production all the specifications are satisfied, and the item is conforming.Further measurements have been taken to assess the conformity of the device size: the total length of the device is within specification.The avenir stem was returned for investigation, however none of the instruments used for the surgical procedure (reamer and trial stem) were returned, nor item# and lot# were provided.With the available information, no device issue was found and the root cause is unknown.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.

• Brand Name: AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16529414
• Report Number: 0009613350-2023-00109
• Device Sequence Number: 14114623
• Product Code: LZO
• UDI-Device Identifier: 00889024590977
• UDI-Public: (01)00889024590977(17)270926(10)3123908
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.06010.004
• Device Catalogue Number: 0106010004
• Device Lot Number: 3123908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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
• 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
• Patient Sex: Prefer Not To Disclose