MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: remains implanted.Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma em med catalog #: 161469 lot #: 937090, medical product: oxf uni tib tray sz d rm pma catalog #: 154725 lot #: 677380.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00615, 3002806535-2019-00617.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent initial right knee arthroplasty.Subsequently, the patient experienced severe pain constantly with some instability.
Event or Problem Description
It was reported that patient underwent initial right knee arthroplasty.Subsequently, the patient experienced severe pain constantly with some instability.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Two radiographs taken on an unknown date were provided for analysis with cmp-0521846: one anteroposterior and one mediolateral.The right knee implant components appear adequately sized and positioned.In the mediolateral x-ray, third body debris is visible in the posterior joint space.This could be a bone fragment or bone cement that was not removed during surgery, which may have articulated with the bearing surfaces and contributed to the reported pain and instability.With a height of 1.83 m and a weight of 135.2 kg at the time of surgery, the patient had a bmi of 40.4 (obese).Two years after surgery (only post-op time point for which scores were provided), the patient presented excellent kss scores, as well as an oxford knee score of 37, which seem to indicate good implant performance.An adverse event, described as 'severe pain constantly with some instability', was reported.It is not possible to determine the root cause of the reported adverse event with the available information device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8821443
• Report Number: 3002806535-2019-00616
• Device Sequence Number: 11519984
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: 05019279786220
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 02/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 784790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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
• Patient Weight: 61