MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH WAGNER CONE PROSTHESIS, TRIAL STEM, PROXIMAL, 125° 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	01.00569.216
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00518.0009613350-2023-00111.The newly provided pictures allowed to identify two additional products involved in the event, namely the trial distal and trial proximal part.A review of these pictures found no evident defects or deformation of the two parts.However, no conclusion can be drawn on the conformity of the products as they were not returned for product evaluation.The wagner stem was returned an visual examination was performed.Visual examination found no signs of damage or usage.A dimensional analysis was performed: a representative feature of the device was taken to further confirm the dimensional correctness of the item.All the measurements taken are conform.Wagner stem and trial proximal: review of the device history record identified no deviations or anomalies during manufacturing that might have contributed to the reported event.Trial distal: review of manufacturing records cannot be performed without product identification.Devices are used for treatment.A single frontal static fluoroscopic intraoperative image of the left hip with presence of a left total hip arthroplasty was provided and reviewed by an health care professionnel.Although limited by fluoroscopic technique, total hip arthroplasty appears normally aligned and intact.The femoral head component is not seen, potentially because image was acquired prior to placement or because of density of overlying acetabular cup.No periprosthetic abnormality detected.Limited assessment of the bones demonstrates no obvious acute abnormality.Overall fit and alignment of the implants as well as bone quality appears grossly unremarkable.No signs of loosening, wear, radiolucency, or any contributing factors detected.The wagner stem was returned for investigation and showed no signs of non-conformance.The trial proximal part was not returned for evaluation.However, manufacturing records identified no deviations or anomalies during manufacturing that might have contributed to the reported event.The trial distal part was not returned for evaluation.Moreover, as lot number is missing, it was not possible to review the manufacturing records for this item.With the available information a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during the surgery of the right hip at time of implantation the implant size 16 mm went in loose so the surgeon changed to size 18 mm implanted and went in without issue.Due diligence was performed; to date whatever additional information received, all have been included in this report.

• Brand Name: WAGNER CONE PROSTHESIS, TRIAL STEM, PROXIMAL, 125° 16
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 16545941
• Report Number: 0009613350-2023-00110
• Device Sequence Number: 20455756
• Product Code: LZO
• UDI-Device Identifier: 00889024282513
• UDI-Public: (01)00889024282513(11)060925(10)4500252041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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: 01.00569.216
• Device Catalogue Number: 01.00569.216
• Device Lot Number: 4500252041
• 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: 02/22/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female