MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 4; KNEE ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the patient had a partial knee arthroplasty implantation surgery and approximately 8 years later a revision surgery was performed due to unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Medical device: oxf twin-peg cmntd fem md pma; item# 161469; lot# 703020; oxf uni tib tray sz c lm pma; item# 154722; lot# 810720; oxford resection 3pk strk 6 h; item# 506124; lot# 948229.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00331 and 3002806535-2022-00333.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).Investigation results are now available.During the investigation it was concluded that product did not fail to meet expectations; the revision took place due to progression of arthritis.Given this information, this complaint is not reportable and this medwatch will be voided.Please delete this report 3002806535-2022-00332 from your records.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 4
• Common Device Name: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15091774
• Report Number: 3002806535-2022-00332
• Device Sequence Number: 17387000
• Product Code: NRA
• UDI-Device Identifier: 05019279785940
• UDI-Public: (01)05019279785940(17)190904(10)376980
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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): 09/07/2022

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: Lay User/Patient
• Device Expiration Date: 09/04/2019
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 376980
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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 Age: 78 YR
• Patient Sex: Female