MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ M; KNEE PROSTHESIS

Model Number N/A

Device Problem Migration (4003)

Patient Problems Joint Dislocation (2374); Reaction (2414)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf anat brg rt md size 4 pma, catalog #: 159576, lot #: 6003906, medical product: oxf uni cmntls tib sz c rm size 4 pma, catalog #: 166575, lot #: 6187657.Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00008, 3002806535-2017-00009.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, the patient was revised due bearing dislocation.The patient had been walking with the dislocation for 3 months.When the surgeon opened the knee, metallosis was present in the soft tissue.

Event Description

It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, the patient was revised due bearing dislocation.The patient had been walking with the dislocation for 3 months.When the surgeon opened the knee, metallosis was present in the soft tissue.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays 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: OXFORD PH3 CEMENTLESS FEM SZ M
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8211689
• MDR Text Key: 131889428
• Report Number: 3002806535-2019-00010
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154926
• Device Lot Number: 6171639
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 06/20/2019
• 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: 75 YR