MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, 125, UNCEMENTED, 16, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

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 is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 product was returned for inspection.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 were confirmed as correct.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.All manufactured items were double checked for dimensional correctness.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00110, 0009613350-2023-00111.This follow-up report is being submitted to relay additional information.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 professional.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 Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Gender update provided.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 Description

No further event information available at the time of this report.

• Brand Name: WAGNER CONE PROSTHESIS, 125, UNCEMENTED, 16, TAPER 12/14
• Type of Device: 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: 15561450
• MDR Text Key: 302773995
• Report Number: 0009613350-2022-00518
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024593183
• UDI-Public: (01)00889024593183(17)241130(10)3013909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191781
• 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,Followup,Followup,Followup
• Report Date: 03/13/2023

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: N/A
• Device Catalogue Number: 01.00561.216
• Device Lot Number: 3013909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/26/2022; 01/03/2023; 02/22/2023
• Supplement Dates FDA Received: 11/10/2022; 01/30/2023; 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female