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

Model Number 01.00569.116

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00518 and 0009613350-2023-00110.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.

• Brand Name: WAGNER CONE PROSTHESIS, TRIAL STEM, DISTAL, 16
• Type of Device: 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: 16545990
• MDR Text Key: 311391077
• Report Number: 0009613350-2023-00111
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024282391
• UDI-Public: (01)00889024282391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 01.00569.116
• Device Catalogue Number: 01.00569.116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female