MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BIPOLAR METAL SHELL 48 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 04/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 01167.

Event Description

It was reported the polyethylene liner would not seat in the acetabular shell.Another liner was used to complete the procedure.There was no patient injury as a result of the malfunction.No additional information.

Manufacturer Narrative

Upon reassessment of the reported event, the shell was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the shell was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: BIPOLAR METAL SHELL 48 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11737116
• MDR Text Key: 248286210
• Report Number: 0002648920-2021-00102
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115354
• UDI-Public: (01)00889024115354(17)300331(10)64731146
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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: 00-5001-048-00
• Device Lot Number: 64146944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#00500104728LINER 28MM LOT#64627519; CAT#802202802ZB 12/14COCR HD28MMLOT#64822650