MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM XL PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the vacuumed sealed sterile package had a hole in the plastic, another device was used for the procedure.

Manufacturer Narrative

(b)(4).The reported event (damaged outer barrier) has been confirmed through visual inspection of photographs provided, which confirms the inner sterile barrier (pouch) is damaged.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be the transit damage.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.

Event Description

It was reported that the vacuumed sealed sterile package had a hole in the plastic, another device was used for the procedure.

• Brand Name: OXF TWIN-PEG CMNTD FEM XL PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8974263
• MDR Text Key: 216766342
• Report Number: 3002806535-2019-00739
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438266
• UDI-Public: 05019279438266
• Combination Product (y/n): N
• PMA/PMN Number: PO10014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 161471
• Device Lot Number: 2225417
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1