MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AGC MOLDED INTERLOK POSTERIOR STABILIZED TIBIAL TRAY 10MM X 80MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Scar Tissue (2060); Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - agc interlok femoral component 70mm left catalog #: 152846 lot #: 3166336.The complainant has indicated that the product is not available to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address tibial loosening approximately fourteen (14) months post-operatively.Initial operative notes did not identify any intraoperative complications.Revision operative notes noted excessive scar tissue and the tibial component was loose and easily removed.The femoral component appeared to be well-fixed.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
This event has been reviewed with supplemental medical documents and has been determined nonreportable.The initial report was submitted erroneously.The patient fell down some stairs and onto concrete, resulting in loosening/instability.The devices are not believed to have contributed to this event.Please void the initial report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: AGC MOLDED INTERLOK POSTERIOR STABILIZED TIBIAL TRAY 10MM X 80MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11692384
• Report Number: 0001825034-2021-01128
• Device Sequence Number: 11508330
• Product Code: JWH
• UDI-Device Identifier: 00880304007772
• UDI-Public: (01)00880304007772(17)220911(10)568160
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K921182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2021

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: 09/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 155362
• Device Lot Number: 568160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 05/10/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/06/2021; 05/26/2021
• 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 Age: 47 YR