MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER MAXERA CUP LINER AND SHELL WITH PLASTIC BARRIER 40MM I.D. 52 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problems Osteolysis (2377); No Information (3190)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported patient is experiencing squeaking from left hip approximately three years post-implantation.The patient has not undergone any treatment; however, is under observation.

Manufacturer Narrative

Reported event was confirmed as the x-ray review indicated implant impingement.Health professional x-ray review states that left total hip arthroplasty x-rays show excessive anteversion and bones appear generally osteopenic, which places patient at risk for posterior rim impingement.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

Manufacturer Narrative

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: ZIMMER MAXERA CUP LINER AND SHELL WITH PLASTIC BARRIER 40MM I.D. 52 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6415439
• MDR Text Key: 70432615
• Report Number: 0001822565-2017-01711
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PEXPORT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00151505240
• Device Lot Number: 62208370
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PN00771100900 LN62243382 FEMORAL STEM; PN00877704001 LN2660685 FEMORAL HEAD
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 79