MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR STD NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Migration (4003)

Patient Problems Pain (1994); Local Reaction (2035); Tissue Damage (2104)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:010000661, lot number: 3837251, brand name: g7 shell; catalog number: 010000925, lot number:3471537, brand name: g7 liner; catalog number: 12-151307, lot number: unknown, brand name: echo femoral stem; catalog number:163669, lot number:130620, brand name: cocr modular head.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02985, 0001825034-2019-03001, 0001825034-2019-02986.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient underwent an left knee arthroplasty.Subsequently was revised due to pain, loosening, wear, disassociation, implant fracture and metallosis approximately three (3) months post implantation.It was noted through x-ray loosening and slippage of the acetabular liner.During revision, the liner was identified to be delaminated and fractured.With head coming in contact to the shell.The additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4; g4; h2; h3; h6.Reported event was confirmed by review of medical records noting patient experiencing pain increasing over the last month.Significant metallosis and blackened tissue noted in the joint along with significant wear of the head.The liner had delaminated piece of the protruding circumferential ring, which was supposed to fit into the shell was sticking out perpendicular.The edge of the shell and clearly come in contact with head.New liner placement was attempted three times and was unable to tighten in place.The shell was removed with concern of locking mechanism.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: 32MM MOD HEAD COCR STD NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8790916
• MDR Text Key: 151046029
• Report Number: 0001825034-2019-02986
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163669
• Device Lot Number: 130620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• 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 Weight: 93