MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL SM COCR SML; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that the foam stuck to implant which made it difficult to open the packaging without compromising the sterility of the product.

Manufacturer Narrative

(b)(4).Complaint summary: the complaint states, it was reported that the foam stuck to implant.This event did not occur during surgery.No patient involvement.On visual inspection it can be confirmed that the top foam has adhered to the tyvek lid.Dimensional check of foams confirms compliance to specification.The packaging does not function as designed as the foam should not adhere to the tyvek lid.The complaint is related to the functional performance of the device as it provides protection and contributes to the sterile barrier.The most likely root cause is that the top foam had stuck to the lid when the blister was sealed due to the implant being too snug in the blister and causing the top foam to bulge.If the packaging configuration of the product does not allow a gap between the foam and the coated lid, the lid could get stuck to the foam during sealing process.The thickness of the top foam has been changed, which in turn increases the gap between the top foam and tyvek lid, therefore reducing the probability that the top foam will adhere to the tyvek lid during the sealing process.This change was implemented following the manufacture of the lot number in this complaint.Issue evaluation ie-11839 has previously been raised for a similar reported event, and resulted in a correction to change to the packaging configuration for the item number within this complaint.Health hazard evaluation hhe-2020-00082 was raised to assess the risk of the top foam adhering to the tyvek lid.This hhe resulted in a no field action recommendation.From the information currently available, there is no evidence to suggest that the product left the company non-conforming to specification at the time of manufacture or regulatory compliance.No further actions are deemed necessary at this time.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The risk is deemed as low.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the foam stuck to implant which made it difficult to open the packaging without compromising the sterility of the product.

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL SM COCR SML
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11655217
• MDR Text Key: 245110135
• Report Number: 3002806535-2021-00118
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 166941
• Device Lot Number: J6895195
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1