MAUDE Adverse Event Report: BIOMET UK LTD. MLRY-HD RNGLC SHL 62MM/L24; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been requested for return from (b)(6) to zimmer biomet uk for evaluation.When the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During inspection of recirculated product upon receipt at zimmer biomet's warehouse in (b)(6), it was discovered that the sterile inner packaging (pouch) was damaging, thereby breaching the sterile barrier.

Manufacturer Narrative

(b)(4).The products were returned to biomet for evaluation and forwarded to a complaints and vigilance engineer for investigation who has reported that upon visual inspection it was confirmed that the parts had holes in inner sterile packaging, in alignment with the fins of the shell showing multiple abrasions, indicating that abrasion of the packaging at these points over time had resulted in the breach.A review of the mallory head ifu and packaging shows warnings regarding packaging inspection and damage.A review of the manufacturing history records confirms no abnormalities or deviations reported.The cause of the damage to the mallory head shells is confirmed as inadequate packaging design which has been re-mediated through (b)(4) as stated above.No complaints have been received on the mallory-head packaging for this failure mode to date.

Event Description

The inner pouches were damaged.

• Brand Name: MLRY-HD RNGLC SHL 62MM/L24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7302053
• MDR Text Key: 101577992
• Report Number: 3002806535-2018-00405
• Device Sequence Number: 1
• Product Code: KWY
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: 104162
• Device Lot Number: 3501503
• Other Device ID Number: SEE H10 NARRATIVE
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1