MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; OXFORD HXLPE BEARINGS

Catalog Number 159569

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

Patient Problems Pain (1994); Scarring (2061)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- oxf uni tib tray sz c lm pma, item 154721, lot 309300, therapy date - device remains implanted, oxf twin-peg cmntd fem sm pma , item 161468, lot 124850, therapy date - device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01163 and 3002806535-2018-01165.

Event Description

The patient underwent a right partial knee arthroplasty.Subsequently it was reported that the patient suffered an episode of sharp right knee pain on medial side of the patella secondary to synovitis and scar irritation.No medical intervention was required.

Event Description

It was reported on that the patient suffered an episode of sharp right knee pain on medial side of the patella secondary to synovitis and scar irritation.No medical intervention was required.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.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 SM SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8008478
• MDR Text Key: 125098080
• Report Number: 3002806535-2018-01164
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Catalogue Number: 159569
• Device Lot Number: 800600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 82