MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING (PS) LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Loss of Range of Motion (2032)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#:42500006001;femur cemented (ps) narrow left size 6; lot#: 63690665; item#:42532006701;tibia cemented 5 degree stemmed left size d; lot#: 63727290; item#:42540000029; all poly patella cemented 29 mm diameter; lot#: 63785212; this complaint was confirmed by review of returned device.Visual examination of the returned device confirms the shim has one each of components 1 and 2 disassembled / missing.Device history record (dhr) was reviewed and no discrepancies were found.This device is confirmed to have been a part of the investigation, where field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2021 - 00044.
Event or Problem Description
It was reported a patient underwent an initial left tka approximately 3.5 years ago.Subsequently, the patient underwent a manipulation under anesthesia and corticosteroid injection due to stiffness/decreased rom caused by adhesions approximately 3 weeks later.

• Brand Name: ARTICULAR SURFACE FIXED BEARING (PS) LEFT 11 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11401751
• Report Number: 0001822565-2021-00583
• Device Sequence Number: 14266869
• Product Code: MBH
• UDI-Device Identifier: 00889024237094
• UDI-Public: (01)00889024237094(17)220831(10)63753072
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512400511
• Device Lot Number: 63753072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/02/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68