MAUDE Adverse Event Report: BIOMET UK LTD. MLRY-HD 3HOLE RLC SHL 54MM/L24; HIP PROSTHESIS

Model Number N/A

Device Problems Positioning Failure (1158); Fitting Problem (2183); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/27/2018

Event Type  Injury  

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

During the thr procedure, upon insertion of acetabular components, the surgeon could not lock the liner into the 54 mm shell.After several attempts, the surgeon decided to replace this component with 56 mm shell.This caused 35 minutes delay in the procedure.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

During the thr procedure, upon insertion of acetabular components, the surgeoun could not lock the liner into the 54 mm shell.After several attempts, the surgeon decided to replace this component with 56 mm shell.This caused 35 minutes delay in the procedure.

Manufacturer Narrative

(b)(4).Product has been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.This happened in a the case with dr.Vijay narasimman at balaji hospital.Once the mh cup 54 has been implanted with screw in the patient body and they were trying to lock the liner with cup using biomet 32mm liner pusher instrument.But the liner was not at all locking after many times of attempt.When removed and checked the shell had a damaged ring in the shell.That ring has not allowed the poly to get lock with the shell.The product was taken out and patient was implanted with 56 shell.This event did occur during surgery.35 minute delay to surgery.Visual inspection of the mallory shell 3 hole 54mm item 11-104154 lot zb170701 shows that the locking ring item 105454-3 is deformed and is badly damaged with a series of dents with resulting burrs caused by the material displacement.The root cause of the reported event could not be determined but the most likely cause is that during implantation into the acetabular the impaction instrument was incorrectly located resulting in the damage to the locking ring which would stop the ring engaging with the location groove in the ringloc liner.A review of the complaints database shows that we have received no reported events for liner would not seat/lock for the same item number 11-104154 prior to the reported event.Risk assessment: -the line which covers the risk reported in the complaint is: line item 45 hazard: ring dislodged during shell impaction.-failure cause: poor or incorrect surgical technique or wrong instruments.-effect on patient: patient suffers the effects of surgical delay.-the severity associated with the above line is 4.-this gives a severity score of s-4 -the actual severity score is s-1 (no patent harm) which is lower than the risk file.Occurrence rate assessment: -dec 2015 to dec 2018: 2407 items sold the given period.-1 complaint reported during the time period.-occurrence ratio: 1:2407 -risk score: severity 4 x occurrence 2 = 8 (medium risk) -the severity of the reported event and calculated occurrence for this complaint are in line with the risk file.-the overall score is medium risk on this occasion there was a 35-minute delay in surgery but this did not result in any adverse health consequences to the patient this would change the severity to s1 resulting in an overall risk score of s1 x p2 = 2 (low risk).No corrective or preventive actions are deemed necessary at this time.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

During the thr procedure, upon insertion of acetabular components, the surgeoun could not lock the liner into the 54 mm shell.After several attempts, the surgeon decided to replace this component with 56 mm shell.This caused 35 minutes delay in the procedure.

• Brand Name: MLRY-HD 3HOLE RLC SHL 54MM/L24
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8273199
• MDR Text Key: 133943991
• Report Number: 3002806535-2019-00073
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K861114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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: 11-104154
• Device Lot Number: 6096458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR