MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A/C2A ACETABULAR SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Osteolysis (2377); Reaction (2414)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products - 28mm m2a mod head -3mm nk/ pn 11-163661/ ln 529580, m2a-t m/h rad sld/apx shl 48mm/ pn 15-104048/ ln 830740, bi-metric cdh por n/c 11x134/ pn 162309/ ln 447730.Customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 report: 0001825034-2017-02543.

Event Description

It was reported by patient's legal counsel that patient had a right hip revision approximately 13 years post implantation due to rejection of metal on metal components.It was further reported that patient had large visible pseudotumors, osteolysis, and bony necrosis as well as metallosis, elevated metal ions and bone loss.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A 28mm m2a mod head -3mm nk, part # 11-163661 from lot 529580, was returned and evaluated against the complaint.The head is scuffed such that part of the finish has become hazy and dull.Scratching and dried debris were also observed on the head.A m2a taper 37/28mm liner, part # 15-105000 from lot 393430, was returned and evaluated against the complaint.The liner is assembled with the returned cup.The finish of the inner radius has become hazy and dull.Foreign debris was also observed on the inner radius.The liner is scratched.Additional information provided does not change the root cause of the previous investigation.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: M2A/C2A ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6511097
• MDR Text Key: 73370243
• Report Number: 0001825034-2017-02542
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042841
• 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,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 15-105000
• Device Lot Number: 393430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR