MAUDE Adverse Event Report: BIOMET UK LTD. VANG CR POR/HA FEM - LT 72.5

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

Crack in plastic prosthesis box for vanguard femur.Implant unsterile and therefore not used in case.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The event reports that the outer sterile packaging (blister) is damaged.This event occurred during surgery.An alternative implant was used to complete the surgery.No harm was reported.The complaint has been confirmed following review of the returned packaging, which confirmed the outer sterile packaging (blister) is damaged.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified no similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot number.The reported event is covered by inst 4.4.1.9 input output risk table ¿ sterile device packaging, revision 03.The severity of the reported event and the calculated occurrence for all similar events in the last 3 years are in line with this risk file.The overall risk score is low.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The ifu provided with the device states to check the packaging for damage before use.The likely condition of the device when it left zimmer biomet is conforming to specification.The correct packaging materials and procedures have been used during the packaging process.The likely cause of the reported event is transit damage.This device falls within the scope of capa ca-02643, the purpose of which was to correct an issue with blister 5400000419, which was found to have thin walls.This capa was closed effectively in jul 2017, following the manufacture of the lot in the reported event.Hhe 2017-292 was raised to assess the risk of product in the field, which resulted in a no field safety correct action decision.This device also falls within the scope of capa ca-03419, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this capa, the pouch is being improved to use a stronger material (nylon).Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.

Event Description

Crack in plastic prosthesis box for vanguard femur.Implant unsterile and therefore not used in case.

• Brand Name: VANG CR POR/HA FEM - LT 72.5
• Type of Device: VANG CR POR/HA FEM - LT 72.5
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9509357
• MDR Text Key: 189895529
• Report Number: 3002806535-2019-00948
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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: 167054
• Device Lot Number: 3810879
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1