MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Item#: 42500006001; femur cemented (ps) narrow left size 6; lot#: 63690665; item#: 42512600514; articular surface fixed bearing (cps) left 14mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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: 3007963827-2021-00289 and 3007963827-2021-00287.
Event or Problem Description
Initial left total knee arthroplasty approximately 4 years ago, mua on one month later due to stiffness, 1st revision approximately 3 years later due to instability and subsequently 2nd revision last month due to pain and swelling after a fall.The patient fell due to unknown reasons.The tibia and femur components were exchanged without complications, patella remained intact.
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) was reviewed and no discrepancies were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: possible periprosthetic lucency surrounding the femoral component; also possible periprosthetic lucency surrounding the anterior of the tibial component; image 1 demonstrates soft tissue swelling; otherwise unremarkable appearance; overall fit and alignment appears normal; no wear or contributing factors; no causes for pain are identified.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: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12810664
• Report Number: 3007963827-2021-00288
• Device Sequence Number: 4629421
• Product Code: JWH
• UDI-Device Identifier: 00889024246676
• UDI-Public: (01)00889024246676(17)270731(10)63727290
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K122765
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006701
• Device Lot Number: 63727290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Female
• Patient Weight: 68 KG