MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 26 MM I.D. FOR USE WITH 40/41 MM O.D. SHELLS; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(6).

Event Description

It was reported that while assembling the femoral head into the liner, the liner locking ring was deformed causing the implants not to mate.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This report is being submitted to relay additional information.The device was returned to the manufacturer for evaluation.The liner was reviewed and verified the c-ring to be deformed.The c-ring shows no other damage.The liner and c-ring were able to fully mate during a technician analysis with no issues and no damage was found on the liner where the c-ring seats to the liner.Device history record (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.

• Brand Name: LINER 26 MM I.D. FOR USE WITH 40/41 MM O.D. SHELLS
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 7419640
• MDR Text Key: 105414697
• Report Number: 0002648920-2018-00284
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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: 00500104026
• Device Lot Number: 63891347
• Other Device ID Number: (01) 00889024115231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1