MAUDE Adverse Event Report: . OXF ANAT BRG LT MD SIZE 4 PMA; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz c lm pma catalog #: 154722, lot #: 971290, medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 387840.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-0009, 3002806535-2020- 00011.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
Event or Problem Description
It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to pain was performed.
Additional Manufacturer Narrative
(b)(4).The following sections were updated: b4, d10, g4, h2, h3, h6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.D11: medical product: oxf uni tib tray sz c lm pma catalog #: 154722, lot #: 971290.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 387840.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00009, 3002806535-2020- 00010.H3 other text : product not returned.
Event or Problem Description
It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to pain was performed.

• Brand Name: OXF ANAT BRG LT MD SIZE 4 PMA
• Common Device Name: KNEE PROTHESIS
• Manufacturer (Section D): .; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9568025
• Report Number: 3002806535-2020-00011
• Device Sequence Number: 546724
• Product Code: NRA
• UDI-Device Identifier: 05019279785940
• UDI-Public: 05019279785940
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P01004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 03/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 276170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/06/2020
• 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: Hospitalization; Required Intervention