MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Unstable (1667); Metal Shedding Debris (1804)

Patient Problems Necrosis (1971); Pain (1994); Reaction (2414)

Event Date 11/18/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products: 00771300600, modular femoral stem, 61856490.The 00784802201, modular neck bb 12/14 neck taper, 61851037.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2018-00553.

Event Description

It was reported by the patient's legal counsel that the patient underwent a right total hip arthroplasty.Subsequently, the patient was revised due to metallosis, corrosion, pseudo tumor, pain, and instability.Intraoperative findings included: necrosis of the abductors, adverse local tissue reaction consistent with metallosis and metal debris in the tissue, metallic debris in the abnormal tissue around the acetabulum, and blackened corrosion at the head/neck junction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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

Reported event was unable to be confirmed due to limited information received from the customer.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.Multiple mdr reports were filed for this event, please see associated report(s): 0001822565 - 2018 - 02974.

Manufacturer Narrative

Concomitant medical products: item# 00875705001 shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners lot# 61903752.Item# 00875200932 liner elevated rim 32 mm i.D.Size hh for use with 50 mm o.D.Size hh shell lot# 61956668.Reported event was confirmed by review of operative notes.Revision op note shows the patient experienced pain, leg length discrepancy.Aspiration showed no infection.The right hip was found unstable, subluxation.Cup was found about 60 degrees.Necrotic tissue, some dark tissues was found, which was consistent with metallosis.Slight corrosion and dark, black debris was found on the neck.The cup was severely abducted, the elevated liner was placed in the posterior inferior quadrant of the acetabulum, about 7o¿clock.Based on the op notes, the cup was abducted and the liner was positioned in the posterior inferior quadrant of the acetabulum, about 7 o¿clock, which likely contributed to the instability.The potential impingement between the neck and the elevated liner is likely to increase the micro-motion between the neck and stem, and the head and neck, which could potentially lead to corrosion.However, other factors(e.G.Patient activity, tissue condition, etc.) cannot be determined.Therefore, the root cause of reported event cannot 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.Additional mdr's submitted for this event: 0001822565 - 2018 - 06521.

Event Description

It was reported by the patient's legal counsel that the patient underwent a right total hip arthroplasty.Subsequently, the patient was revised due to metallosis, corrosion, pseudo tumor, pain, and instability.Intraoperative findings included: necrosis of the abductors, adverse local tissue reaction consistent with metallosis and metal debris in the tissue, metallic debris in the abnormal tissue around the acetabulum, and blackened corrosion at the head/neck junction.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: COCR FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7244666
• MDR Text Key: 99124222
• Report Number: 0001822565-2018-00552
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2018

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: Physician
• Device Expiration Date: 06/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 61530640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 06/29/2018; 11/09/2018
• Supplement Dates FDA Received: 05/31/2018; 08/13/2018; 11/19/2018
• 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