MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED RIGHT 11MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Reaction (2414); No Code Available (3191)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device whereabouts are unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: 42532007502, tibia cemented 5 degree stemmed right size f, lot# 63603170; mdr: 3007963827-2020-00336.42500806802, femur trabecular metal posterior stabilized standard porous, lot# 63766860; mdr: 3007963827-2020-00337.
Event or Problem Description
Patient called stating he underwent a right tka.Subsequently, approximately 3 years post procedure the patient was revised due to poly failure causing metal debris in the knee.Patient is seeking compensation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: therapy performed due to pain, instability, weakness, use of assistive device, performed thereafter for left tka and right knee ongoing pain, patient has 3/5 mmt for knee extension/flexion; patient has crepitus around knee, limp right leg, failed conservative therapy treatment, adhesion/scar tissue removal, instability and pain that implant adl, very thickened black synovium consistent with metallosis, metal stained synovium, tibial insert had disengaged from tray, burnishing of posterior condyles consistent with metal wear, tibial tray showed significant wear with locking mechanism destroyed, removed femoral and tibial components, debridement of metal stained synovium, patella and patella component well fixed and tracked well.Complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED RIGHT 11MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11080502
• Report Number: 0002648920-2020-00541
• Device Sequence Number: 13631975
• Product Code: JWH
• UDI-Device Identifier: 00889024241039
• UDI-Public: (01)00889024241039
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42521400811
• Device Lot Number: 63378992
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 102