MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00129, 0001822565-2021-01619, 0002648920-2021-00151, and 0002648920-2021-00152.Medical devices: cr-flex pct fem f-r minus catalog#: 00595001606 lot#: 63525591; stemmed tibial component precoat size 5 catalog#: 00598004701 lot#: 63565275; all poly patella standard size 32 mm diameter 8.5 mm thickness cemented catalog#: 00597206532 lot#: 63534851.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its current location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a right knee revision approximately four years post-implantation due to a deficient posterior cruciate ligament.Attempts to obtain additional information have been made; however, no more is available.
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.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.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.

• Brand Name: ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11976655
• Report Number: 0001822565-2021-01619
• Device Sequence Number: 3624365
• Product Code: JWH
• UDI-Device Identifier: 00889024208018
• UDI-Public: (01)00889024208018(17)220131(10)63564755
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00595204010
• Device Lot Number: 63564755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention