MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 26 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 2 of 2 mdrs filed for the same patient (reference 0002648920-2016-03319).

Event Description

It was reported that the liner couldn't be assembled to the cup.The surgery was finished with alternate device.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Medical product shell catalog#: 00500104500 lot#: 63152863.A multipolar bipolar shell and liner were returned for review.As returned, one tab of the lock ring was seized in the lock ring groove.Damage/gouges are seen on the mating surface of the poly liner.This damage appears to be witness marks from the lock ring, indicating that the ring was seized during the initial attempt to install.The interfacing diameters of both devices and the lock ring groove are found to be conforming to print specifications.After the lock ring was removed from the shell damage was seen on the seized tab.Dimensional measurements of the lock ring are conforming to print specifications.The lock ring and liner were reinstalled in the shell, seating/functioning as intended.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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 44/45/46 MM O.D. SHELLS
• 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: 6139722
• MDR Text Key: 61294035
• Report Number: 0002648920-2016-03319
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• 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: 00500104426
• Device Lot Number: 63435179
• Other Device ID Number: (01) 00889024115316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1