MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR RED/DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Scar Tissue (2060)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: cat# 15-106048 m2a-38 cup non flared sz 48mm lot#773420; cat# 11-173665 m2a 38mm mod hd+9mm nk no skrt lot#608880.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00401, 0001825034 - 2021 - 00402.

Event Description

It was reported the patient underwent a right hip revision approximately 11 years post implantation due to adverse location tissue reaction (altr), scar tissue, pseudocapsule, bone remodeling, and in-vivo corrosion.Patient's operative records indicated that there was scarring down of the gluteus maximus fascia to the underlying bursa and gluteus medius tendon.There was a moderate amount of slightly turbid fluid in the joint space posterior to the hip communicating with the trochanteric bursa space and there was open communication distal to the external rotators.There was a dense amount of yellowish tissue filling the hip joint space and the deepest part of this was avascular.There was small areas of black corrosive change on the trunnion.One could see the oxidation changes in the inner aspect of the head.There was an exuberant amount of bone growth laterally and anteriorly relative to the acetabular component and a trial reduction was done with a 6mm trial head and there was immediate impingement and instability.Excessive bone was removed and the impingement was dramatically decompressed.Prominent bone was also removed from the greater trochanter anteriorly.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of op notes.Operative notes were provided and reviewed by a healthcare professional.Patient underwent a rtha on (b)(6) 2009 due to hip dysplasia and osteochondroma; no intraoperative complications were noted.Patient was revised on (b)(6) 2020 due to altr, scar tissue, pseudocapsule, bone remodeling, and in-vivo corrosion.There was scarring down of the gluteus maximus fascia to the underlying bursa and gluteus medius tendon.There was a moderate amount of slightly turbid fluid in the joint space posterior to the hip communicating with the trochanteric bursa space and there was open communication distal to the external rotators.There was a dense amount of yellowish tissue filling the hip joint space and the deepest part of this was avascular.The tissue was sent as a pseudocapsule specimen to evaluate for possible alval.There was small areas of black corrosive change on the trunnion.There was an exuberant amount of bone growth laterally and anteriorly relative to the acetabular component and a trial reduction was done with a 6mm trial head and there was immediate impingement and instability.Excessive bone was removed and the impingement was dramatically decompressed.Prominent bone was also removed from the greater trochanter anteriorly.Head was explanted and replaced with a dual mobility bearing and modular head component.Device history record (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: TAPERLOC POR RED/DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11302943
• MDR Text Key: 231123345
• Report Number: 0001825034-2021-00403
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 12-103206
• Device Lot Number: 328510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR