MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 FOR CEMENTED USE ONLY; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains 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: 0002648920-2021-00142, 0001822565-2021-01500, 0001822565-2021-01501, 0001822565-2021-01502, 0002648920-2021-00143.
Event or Problem Description
It was reported that bilateral patient underwent a left total knee arthroplasty.Subsequently, the patient is experiencing pain, swelling, loss of rom, cannot walk and is confined to a wheel chair.She stated that the surgeon reported to her a catastrophic failure of both knees.The patient also reports that her patella is dislocated and not in the correct place.Attempts have been made and no further information has been provided.
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 dhr for deviations and/or anomalies identified the following related anomalies/deviations, documentation error / corrected, which could be related to the reported event.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 FOR CEMENTED USE ONLY
• 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: 11921592
• Report Number: 0002648920-2021-00144
• Device Sequence Number: 3831976
• Product Code: JWH
• UDI-Device Identifier: 00889024217584
• UDI-Public: (01)00889024217584(17)270831(10)63754935
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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 Model Number: N/A
• Device Catalogue Number: 00598003702
• Device Lot Number: 63754935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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: Other
• Patient Weight: 145