MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA; KNEE ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combined initial and final mdr report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the surgeon did not approve for return.Concomitant medical products: medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 631620, medical product: oxf uni tib tray sz b lm pma, catalog #: 154720, lot #: 733880.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00097, 3002806535-2020- 00098.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.For the item 159541; 1 piece was scrapped with opn numbers as 0020.A review of the complaint database over the last 3 years has found 25 similar complaints for this item code 161468, 14 similar complaints for this item code 154720 and 6 similar complaint for this item code 159541.Trends could not be identified from the complaint history review because the reason for the revision is unknown.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.At this time, no risk assessment can be conducted since the harm or reason for revision has not been reported.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.
Event or Problem Description
It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, a revision due to unknown reasons was performed.

• Brand Name: OXF ANAT BRG LT SM SIZE 4 PMA
• Common Device Name: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9768515
• Report Number: 3002806535-2020-00099
• Device Sequence Number: 19525597
• Product Code: NRA
• UDI-Device Identifier: 05019279785872
• UDI-Public: 05019279785872
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 02/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 372510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/28/2020
• 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
• Patient Age: 65 YR