MAUDE Adverse Event Report: BIOMET UK LTD. EXC ABT RNGLC-X SHELL PC 050MM; ACETABULAR SHELL

Model Number N/A

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign country: event occurred in (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 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 locking ring would not engage with cup when impacted.Subsequently, the surgeon had to remove the locking ring from the newly implanted exceed cup and replace it with a locking ring from another exceed cup.

Event Description

It was reported that the locking ring would not engage with cup when impacted.Subsequently, the surgeon had to remove the locking ring from the newly implanted exceed cup and replace it with a locking ring from another exceed cup.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in denmark.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The event reports that the locking ring in the implanted exceed cup did not lock around the liner when this was impacted.Surgeon had to remove the locking ring from the newly implanted exceed cup and replace it with a locking ring from another exceed cup.The complaint has not been confirmed following review of the returned implant, it cannot be determined how the locking ring has ended up in this condition.Visual inspection shows that the locking ring is damaged and distorted out of shape.Root cause cannot be determined.The locking ring is checked on two occasions during the manufacturing process.I001459 locking ring assembly for exceed abt ringloc gives specific instructions to check the locking ring is inserted correctly.Q000026 final inspection also gives instructions to check the locking ring is inserted correctly.It is likely that the damage occurred whilst attempting to insert the liner but this cannot be confirmed.It is most likely that the device left zimmer biomet control conforming.No corrective or preventative actions needed at this time.It has been determined that this complaint is not a new confirmed quality or manufacturing issue.Complaints are monitored through monthly complaint reviews (reference sop163) in order to identify potential adverse trends.A review of the complaint database has found no similar complaints reported with this item # / lot # combination.A review of the complaints data base for 3 years prior to the notification date has found no similar reported events for this item.The mhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.Risk assessment: this event occurred during surgery.No further harm was reported.The actual severity score is in line with the risk file.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.

• Brand Name: EXC ABT RNGLC-X SHELL PC 050MM
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9719829
• MDR Text Key: 180329981
• Report Number: 3002806535-2020-00085
• Device Sequence Number: 1
• Product Code: KWA
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 131350
• Device Lot Number: 6580495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other