MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM FEMORAL SIZE MEDIUM; PROSTHESIS, KNEE

Catalog Number 154601

Device Problem Device Packaging Compromised (2916)

Patient Problem No Code Available (3191)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(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 follow-up mdr will be submitted.

Event Description

It was reported that during a knee arthroplasty the inner packaging of the femoral component had some kind of leakage; another product was found and used to complete the procedure after an approximate delay of one hour.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).The returned product was evaluated for the reported liquid residue inside the sterile packaging (pouch).The pouch was opened and separated in order that the inside could be checked for liquid residue.There was no evidence of any form of liquid or moisture on the inside of the pouch.The implant was also checked for staining from liquid/moisture from the inside of the pouch.There was no evidence of staining on the implant.The scuffing around the implant and the inner seal starting to separate could have the visual effect of moisture within the pouch due to its opaque effect.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints data base has revealed 2 similar complaints for the reported issue.All 3 complaints are reported from (b)(6).(b)(4).

• Brand Name: OXFORD PARTIAL KNEE SYSTEM FEMORAL SIZE MEDIUM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6504535
• MDR Text Key: 73219988
• Report Number: 3002806535-2017-00231
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 154601
• Device Lot Number: 3246367
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR