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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); No Information (3190)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: the following are associated devices and remain implanted- oxf twin-peg cmntd fem md pma, item # 161469, lot # 372620; oxf uni tib tray sz c rm pma, item # 154723, lot # 478410.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Revision of bearing due to unknown reason.

Manufacturer Narrative

Zimmer biomet (b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Revision of bearing in the right knee due to stretched mcl.Thicker bearing was implanted.The patient sustained an injury to the knee when he stepped into a whole at work, causing valgus instability in the knee and a mild recurrence of his varus alignment.

Event Description

Revision of bearing in the right knee due to stretched mcl.Thicker bearing was implanted.The patient sustained an injury to the knee when he stepped into a whole at work, causing valgus instability in the knee and a mild recurrence of his varus alignment.

Manufacturer Narrative

(b)(4).The reported valgus deformity and joint instability could not be confirmed with the radiographs provided.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
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8389468
• MDR Text Key: 137791179
• Report Number: 3002806535-2019-00238
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 540130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 104