MAUDE Adverse Event Report: BIOMET UK LTD. EXC ABT RNGLC-X SHL HA/PC 056M; HIP PROTHESIS

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Report source, foreign - event occurred in (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the locking ring pinged off when impacting into the bone.This seems to happen with harder bone as it bends the cup causing the ring to ping off.The surgeon was able to re-attach the ring after 10 minutes.No known impact or consequence to the patient.Attempts have been made and no further information has been provided as yet.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product not returned to manufacturer.

Event Description

Locking ring dislodged.It was reported that the locking ring pinged off when impacting into the bone.This seems to happen with harder bone as it bends the cup causing the ring to ping off.The surgeon was able to re-attach the ring after 10 minutes.No known impact or consequence to the patient.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: event date: (b)(6) 2021.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device remains implanted.

Event Description

Locking ring dislodged.It was reported that the locking ring pinged off when impacting into the bone.This seems to happen with harder bone as it bends the cup causing the ring to ping off.The surgeon was able to re-attach the ring after 10 minutes.No known impact or consequence to the patient.

• Brand Name: EXC ABT RNGLC-X SHL HA/PC 056M
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11640719
• MDR Text Key: 247016832
• Report Number: 3002806535-2021-00110
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 05019279117505
• UDI-Public: (01)05019279117505(17)300303(10)6748630
• 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: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2021

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: 131356HA
• Device Lot Number: 6748630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 04/15/2021; 05/14/2021
• Supplement Dates FDA Received: 04/27/2021; 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1