MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00245.3002806535-2021-00246.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
(b)(6) clinical study reported that a patient underwent an initial partial right knee arthroplasty on (b)(6) 2020.Subsequently, the patient experienced pes bursa which onset on (b)(6) 2021.The severity was reported as mild.Treatment: steroid injection.Not device related.Possibly procedure related.Outcome: tolerated.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, b4, b5, g3, g6, h1, h2, h10 additional information received: patient¿s information received: patient name: (b)(6) age: 60 years the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Mymobility clinical study reported that a patient underwent an initial partial right knee arthroplasty on (b)(6) 2020.Subsequently, the patient experienced pes bursa which onset on (b)(6) 2021.The severity was reported as mild.Treatment: steroid injection not device related.Possibly procedure related.Outcome: tolerated.
Event or Problem Description
Mymobility clinical study reported that a patient underwent an initial partial right knee arthroplasty on (b)(6) 2020.Subsequently, the patient experienced pes bursa which onset on (b)(6) 2021.The severity was reported as mild.Treatment: steroid injection.Not device related.Possibly procedure related.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 154723, 1 complaint reported with the item 161469, and 2 complaints reported with the item 159575 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00245-2; 3002806535-2021-00246-2.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG RT MD SIZE 3 PMA
• Common Device Name: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11965376
• Report Number: 3002806535-2021-00247
• Device Sequence Number: 3508400
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2021

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 Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 465190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 08/11/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/29/2021; 08/11/2021
• 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 Age: 60 YR
• Patient Weight: 103