MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem Host-Tissue Reaction (1297)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00630505032, lot number: 61034302, brand name: acetabular liner.Catalog number: 0000801803202, lot number: 61047644, brand name: femoral head.Catalog number: 65771100920, lot number: 60707596, brand name: femoral stem.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.

Event Description

It was reported that during a revision surgery, the new locking ring would not engage with the shell.The surgeon noted that the locking mechanism on the shell had malfunctioned and decided to replace the entire shell.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Implant date was reported incorrectly initially and should be blank.Explant date was reported incorrectly initially and should be blank.Reported event was confirmed by review of op-notes.It states that during the revision procedure, the locking ring did not engage properly, the metal bar at the top portion of the trilogy cup where the locking ring entered was noted to be slightly bent.Device history record 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.

Event Description

No further event information available at the time of this report.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.
• 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: 8735766
• MDR Text Key: 149230987
• Report Number: 0002648920-2019-00466
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00620005422
• Device Lot Number: 61050721
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1