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

Model Number N/A

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported that a hair was found within the inner packaging.Surgery was completed with an identical implant.No consequences or impact to the patient were reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Report source: foreign ¿ germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 PROTHESIS
• 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: 16451254
• MDR Text Key: 310329396
• Report Number: 0009613350-2023-00094
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024503953
• UDI-Public: (01)00889024503953(17)271116(10)3128846
• 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: 04/21/2023

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: 61272846
• Device Lot Number: 3128846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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
• Patient Sex: Prefer Not To Disclose