MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT SIZE D RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 00599401492; femoral component; lot#: 64383462.Item#: 110035368; biomet bc r 1x40 us; lot#: 944aaa2507.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01695.
Event or Problem Description
It was reported the patient underwent a knee procedure 14 years ago with unknown knee products.Subsequently, the patient claims to have had 7-8 surgeries due to infections with the most recent one performed 6.5 months ago.Patient stated she was informed by her doctor at that time she was implanted with a spacer knee implant.Patient states she now only has 30 degree extension in her knee.
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.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review identified no deviations or anomalies during manufacturing related to the reported event.X-rays were provided however they were not sent for further review as the patient has been revised multiple times and the x-rays are not dated to be correlated to the correct complaint.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: FEMORAL COMPONENT SIZE D RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12033725
• Report Number: 0001822565-2021-01696
• Device Sequence Number: 11862963
• Product Code: JWH
• UDI-Device Identifier: 00889024224797
• UDI-Public: (01)00889024224797(17)290430(10)64383462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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 Model Number: N/A
• Device Catalogue Number: 00599401492
• Device Lot Number: 64383462
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: Other
• Patient Weight: 70