MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA; OXFORD CEMENTED FEMORALS

Catalog Number 161469

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- oxf anat brg rt md size 4 pma, item 159526, lot 784790, therapy date - remains implanted, oxf uni tib tray sz d rm pma , item 154725, lot 677380, therapy date - 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: 3002806535-2018-01291 and 3002806535-2018-01292.

Event Description

Patient has extreme difficulty kneeling down and getting back up.

Event Description

It was reported that patient has extreme difficulty kneeling down and getting back up in right knee.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Unique identifier (udi) number: the patient reported extreme difficulty kneeling and getting back up due to pain in the right knee two years after primary oxford pks surgery.The source of the pain may be related to factors such as impingement from osteophytes and a high bmi (the patient is obese).From the available information however, it is not possible to reach a comprehensive conclusion about the source of the pain.A review of the manufacturing history records confirms no abnormalities or deviations reported.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.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 TWIN-PEG CMNTD FEM MD PMA
• Type of Device: OXFORD CEMENTED FEMORALS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8179383
• MDR Text Key: 130875046
• Report Number: 3002806535-2018-01290
• Device Sequence Number: 1
• Product Code: NRA
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 161469
• Device Lot Number: 937090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 135