MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIPOLAR SHELL, MODULAR, 46; HIP PROSTHESIS

Model Number N/A

Device Problem Use of Device Problem (1670)

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

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: bipolar insert, modular, 46/28 item#61272846 lot#3109949.Foreign source: germany.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 - 00514.Currently still implanted.

Event Description

It was reported that during an op, the inlay was found to be slightly tilted in the shell.The surgeon was able to complete the surgery using these same devices.No patient harm was reported, due diligence is in progress for this event; to date no further information has been provided.

Manufacturer Narrative

(b)(4).G2- germany.This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d9; g3; g6; h2; h3; h6; h10.No product was returned, but pictures were provided: review of the pictures was performed.Devices are used for treatment.Review of the manufacturing records shows that all the specifications were met at the moment of production.Product were not returned for investigation, therefore with the available data it is impossible to establish a definitive root cause.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. .

• Brand Name: BIPOLAR SHELL, MODULAR, 46
• 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: 15541933
• MDR Text Key: 301166493
• Report Number: 0009613350-2022-00513
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024503854
• UDI-Public: (01)00889024503854(17)270725(10)3110465
• 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
• Report Date: 11/18/2022

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: 61.27.00-46
• Device Lot Number: 3110465
• Was Device Available for Evaluation?: No
• 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: 10/05/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose