MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIPOLAR INSERT, MODULAR, 54/28; HIP PROSTHESIS

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report site: foreign ¿ germany investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during surgery there was an intra-operative complication as the liner could not be removed from the shell with the intended instrument, which was functional and undamaged.The metal retaining ring could not be pressed together or be detached from the shell.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided.Visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies, during manufacturing related to the reported event.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.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.The following sections were updated:b4, b5, d2,d9, g3, g6, h3, h6, h10.Visual examination of the returned product identified nothing conspicuous other than several light scratches and light indentations.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.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: BIPOLAR INSERT, MODULAR, 54/28
• 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: 16119854
• MDR Text Key: 308444168
• Report Number: 0009613350-2022-00657
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024503977
• UDI-Public: (01)00889024503977(17)260707(10)3081161
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

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: 61.27.28-54
• Device Lot Number: 3081161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/07/2023; 03/24/2023
• Supplement Dates FDA Received: 03/06/2023; 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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: Prefer Not To Disclose