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

Catalog Number 61.27.00-46

Device Problem Separation Failure (2547)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical devices: bipolar insert, modular, 46/28; item# 61.27.28-46; lot# unknown.Report source - foreign: austria.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00096.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 an 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.D10 ¿ associated products: izb 12/14 cocr hd 28mm x 0; item# 802202802; lot# 3089309.The modular bipolar shell, the modular bipolar liner and the head were returned for investigation.Visual examination identified that the items were returned assembled together.As it is possible to see from the side view of the assembled products, the liner is not sitting correctly in the shell, but it is tilted.The outer surface of the shell shows some scratches.The inner surface of the shell as well as the six flutes along the circumference shows some scratches.The outer surface of the liner shows some scratches and dents.Moreover, the six knobs along the circumference are damaged and deformed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event 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 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: 16459535
• MDR Text Key: 310423059
• Report Number: 0009613350-2023-00097
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024503854
• UDI-Public: (01)00889024503854(17)271013(10)3134927
• 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
• Report Date: 06/23/2023

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 Catalogue Number: 61.27.00-46
• Device Lot Number: 3134927
• 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: 02/03/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose