MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL; PROTHESIS, HIPS

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Necrosis (1971); Pain (1994); Metal Related Pathology (4530)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 00771101200 ml taper sz12.5 std offset 60753334 00620205822 tm acet shell 58mm cluster 60629168 00801803202 femoral head sterile product do not resterilize 12/14 taper 60780515 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient had a right total hip arthroplasty.Subsequently, the patient underwent a revision surgery nine (9) years post implantation due to pain and elevated metal ions.The femoral head and liner were revised.During the revision procedure, pseudocapsule, implant corrosion, and bone loss was noted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6 visual examination of the returned product/provided pictures identified the taper of the femoral head exhibits a circumferential groove pattern and dark debris.The poly liner shows damage on the backside of the rim.A portion of the rim is chipped and missing.The stem remains implanted.The head was submitted for further analysis.Analysis determined fretting on >10% of the surface and/or corrosion damage to one or more small areas.Review of the device history records identified no deviations or anomalies during manufacturing for the liner.Root cause unchanged.This complaint was confirmed based on the returned devices and medical records.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.

Event Description

No additional event information to report at this time.

• Brand Name: LINER STANDARD 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18520251
• MDR Text Key: 332946972
• Report Number: 0001822565-2024-00159
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: Lay User/Patient
• Device Expiration Date: 07/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 00630505832
• Device Lot Number: 60741731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2007
• 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: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention