MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANSWER 9X125 COCR LAT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 11-173661 lot number:036230 brand name: m2a 38mm mod hd; catalog number:rd118848 lot number:942430 brand name: m2a 38mmx48mm cup; catalog number:162501 lot number:170890 brand name: answer 9x125 cocr lat.Multiple reports were submitted along with this report 0001825034-2022-00678 and 0001825034-2022-00679.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: failed right total hip replacement with suspected altr from metal on metal bearing.Pseudo capsule and lytic inflammation encountered, gray staining of synovial lining and thickened yellow tan tissue developed and debrided.Corrosion to the trunnion noted and cleaned.Defect behind acetabulum involving posterior portion of the posterior column, cup appeared to be well fixed to the ilium.Black lytic membrane tissue debrided from the hip joint space and allograft bone placed into defect.Noted black material to greater trochanter and debrided.Reported event was confirmed by review of medical records provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause 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.
Event or Problem Description
It was reported that the patient was revised with suspicion of adverse local tissue reaction approximately 15 years post implantation.During the revision there was a pseudo capsule, corrosion, lytic inflammation, gray staining, black lytic membrane material found and bone defect.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ANSWER 9X125 COCR LAT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14250635
• Report Number: 0001825034-2022-00992
• Device Sequence Number: 4774268
• Product Code: JDG
• UDI-Device Identifier: 00880304252660
• UDI-Public: (01)00880304252660(17)310810(10)170890
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K931194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 162501
• Device Lot Number: 170890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2000
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female