MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS; HIP PROSTHESIS

Catalog Number 00500104428

Device Problem Fitting Problem (2183)

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that after the femoral head was implanted then it was seen that shell and liner did not fit each other.Surgery was completed with new implants.

Manufacturer Narrative

This follow up report is being filed to relay additional information.(b)(4).The complaint sample was evaluated and the reported event was not confirmed.As returned, the lock ring was correctly positioned in the groove of the shell.Evaluation with a gauge confirmed that the lock ring groove conformed to print specification.Shell diameters conformed to print specifications where measured.Dimensional measurements of the lock ring are conformed to print specification.The liner exhibits damage to the rim feature and lock ring.Damage of the lock ring suggests that it most likely occurred during removal of the components.The witness marks and gouges noted on the outer diameter of the liner are indicative of possible misalignment during the attempt to assemble the componentry; however it could not be confirmed if the misalignment was due to the installation or the extraction of the device.Damage of the liner is too severe for a complete dimensional analysis.Device history record review identified no deviations or anomalies for the reported devices, related to the event.The liner and shell were used in an approved and compatible combination.Review of complaint history identified no previous complaints for the part lot combination of the reported devices.With the information provided a specific cause for the reported issue could not 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.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 44/45/46 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6086484
• MDR Text Key: 59459906
• Report Number: 0002648920-2016-03271
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 00500104428
• Device Lot Number: 63192063
• Other Device ID Number: SEE H10 NARATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 50