MAUDE Adverse Event Report: BIOMET UK LTD. TAPERLOC BMPC 17.5X155MM 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The implant had the blister intact, but after opening it was verified that the inner container was damaged and not sterile.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned packaging confirms that the inner sterile barrier (pouch) was damaged.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 transit damage.Device history record (dhr) was reviewed and no discrepancies were found.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

The implant had the blister intact, but after opening it was verified that the inner container was damaged and not sterile.

• Brand Name: TAPERLOC BMPC 17.5X155MM 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8691232
• MDR Text Key: 147726653
• Report Number: 3002806535-2019-00501
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 05019279130795
• UDI-Public: (01)05019279130795
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 650-0558BM
• Device Lot Number: 1710516
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1