MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIPOLAR INSERT, MODULAR, 46/28; HIP PROSTHESIS

Catalog Number 61.27.28-46

Device Problem Positioning Failure (1158)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an intra operative complication occurred where by this inlay did not seat properly in the shell.The surgeon tried a second inlay but that also did not seat properly, and could not be removed from the shell.The surgeon removed both the shell and second inlay.Surgery was completed with a new shell and inlay.No known impact or consequence to the patient.Due diligence is in progress for this complaint; to date what additional information that was received has been mentioned in this report, no product has been received yet.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d4, d9, g3, g6, h2, h3, h4, h10.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).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified that the articulating surface, the non-articulating surface and the flat rim of the insert are inconspicuous.The facing surfaces of the insert present some slight material deformation, most likely occurred in the attempt to remove the insert from the shell.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, 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.

• Brand Name: BIPOLAR INSERT, MODULAR, 46/28
• 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: 16465558
• MDR Text Key: 310511211
• Report Number: 0009613350-2023-00098
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024503953
• UDI-Public: (01)00889024503953(17)271122(10)3132386
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 61.27.28-46
• Device Lot Number: 3132386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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
• Patient Sex: Prefer Not To Disclose