MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PE BIPOLAR LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 00500104600, multipolar cup, 63456945.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0002648920 - 2018 - 00173.

Event Description

It was reported that the insert does not fit into the cup because the ring was locked.The surgery was completed with another implant.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.As returned, the liner and poly ring are severely damaged.The poly locking ring is out of place, likely from removal of the femoral head.Subsequently, an indentation was identified on the outer circumference of the liner indicative of an unsuccessful attempt to assemble the liner with the shell/locking ring.The shell was returned with one of two tabs of the locking ring seized in the locking ring groove.Dimensional readings of the locking ring and locking ring groove are conforming to print specifications.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: PE BIPOLAR LINER
• 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: 7329414
• MDR Text Key: 102204431
• Report Number: 0002648920-2018-00174
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00500104428
• Device Lot Number: 63848868
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 03/14/2018; 01/21/2019
• Supplement Dates FDA Received: 04/05/2018; 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 61