MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, 125°, UNCEMENTED, 20, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00363.
Event or Problem Description
It was reported that right coxarthrosis occurred.Patient underwent a revision of the insert for wear, and the stem for mobilization approximately 12 years after implantation.Due diligence is in progress for this complaint.No additional information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
D10.Dural alpha insert neutr ii/36 item # 0100013.709 lot # 2533993.Biolox delta, ceramic femoral head, xl,36/+7, taper 12/14 item #00877503604 lot # 2499971.The product was not returned, but pictures were provided and a review of the pictures was performed.As from the received picture, the stem looks intact; little on growth bone is present on the surface.No visible traces of damage and wearing on the liner.The head it is possible to identify some metal smears on the surface facing the stem.A review of the device history records identified no deviations or anomalies during manufacturing.Review of manufacturing records show that all the requirements were met at the time of production.Therefore, the investigation did not identify a nonconformance related to the issue.With the available information 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.

• Brand Name: WAGNER CONE PROSTHESIS, 125°, UNCEMENTED, 20, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• 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: 14942131
• Report Number: 0009613350-2022-00362
• Device Sequence Number: 17691273
• Product Code: LZO
• UDI-Device Identifier: 00889024485082
• UDI-Public: (01)00889024485082(17)141031(10)2530464
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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 Expiration Date: 10/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 01.00561.220
• Device Lot Number: 2530464
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 68 KG