MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM RIGHT SIZE 3; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: oxford ph3 cementlessfem sz m; item# 154926; lot# 6299751.Oxf uni cmntls tib sz d rm; item# 166577, lot# 6181847.Foreign: singapore.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.The device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to reported event.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
It was reported that the patient underwent a knee arthroplasty and developed infection within the same year.Revision surgery was performed and the bearing was changed.Investigation results are now available.Attempts have been made and no further information has been provided.

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM RIGHT SIZE 3
• Common Device Name: KNEE PROTHESIS
• 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: 14942310
• Report Number: 3002806535-2022-00297
• Device Sequence Number: 6215524
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: (01)05019279786213(17)240106(10)6566520
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 06/06/2024
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 6566520
• 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: 06/10/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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: Unknown