MAUDE Adverse Event Report: ZIMMER, INC. PE INSERT APR 55/28 HOODED; PROSTHESIS, HIP

Model Number N/A

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 10/14/2003

Event Type  Injury  

Manufacturer Narrative

The complaint number corresponding to this medwatch is cmp-(b)(4).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Concomitant medical products - apr screwless shell 4311-00-055, lot 1188294.Apr femoral stem 7416-01-150, lot 1197164.Ball head nh 7210-28-400, lot 1188307.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03808, 0001822565-2017-03812, 0001822565-2017-03687.

Event Description

It was reported by the patient's legal counsel that the patient's left hip was revised approximately eight years post-implantation due to osteolytic lesions.A portion of the patient¿s revision operative report was received, which indicated excision of a pseudocapsule, the presence of osteolytic lesions on the femur and periacetabular region and wear of the polyethylene liner.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/corrected information.Reported event was confirmed by review of operative notes which indicated osteolytic lesions were found along the posteromedial femur as well as along the lateral corner of the trochanter.The liner had significant wear.The periacetabular region was found also to be significantly involved with osteolysis.These lesions were grafted with bone source bone graft.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.

Event Description

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

• Brand Name: PE INSERT APR 55/28 HOODED
• 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: 6609121
• MDR Text Key: 76561978
• Report Number: 0001822565-2017-03811
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 4335-28-055
• Device Lot Number: 1177587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/1995
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR