MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. STANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 542- 12/14 - RIGHT S8; COATED HIP FEMUR PROSTHESIS, MODULAR

Catalog Number PS126Y08

Device Problem Off-Label Use (1494)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusion or information, a supplemental will be filed accordingly.

Event Description

It was reported that a product has been implanted on (b)(6) 2021 whereas the expiration date was (b)(6) 2021.It has also been reported that the stock control has not been performed by zimmer biomet sales representative since 6 months which leads to several stock-out.The instrumentalist was aware of the surgery but forgot to verify expiration dates one week before the surgery.The day of the surgery, the surgeon planned to implant an exception femoral stem size 7, however, during the trials, he realized that size 7 would not fit and that it would take size 8.However, size 8 was expired and surgeon had no other choice to implant the expired stem.

Event Description

It was reported that a product has been implanted on (b)(6) 2021 whereas the expiration date was april 10, 2021.It has also been reported that the stock control has not been performed by zimmer biomet sales representative since 6 months which leads to several stock-out.The instrumentalist was aware of the surgery but forgot to verify expiration dates one week before the surgery.The day of the surgery, the surgeon planned to implant an exception femoral stem size 7, however, during the trials, he realized that size 7 would not fit and that it would take size 8.However, size 8 was expired and surgeon had no other choice to implant the expired stem.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following section has been updated : b4, g3, g6, h1, h2, h3, h5, h6 and h10.The product label received shows that the expiration date of the exception stem reference ps126y08 and batch 0001116228 is april 10, 2021 which correspond to the date mentioned in zimmer biomet erp.So the information reported in the label was right.Moreover, the initial surgery date reported was may 04, 2021 which is 24 days after the expiration date.The product analysis can't be performed as the product was not returned.Due to internal issues, the range of product involved in the event (exception stems) was not supplied and prevented the sales representative to exchange the expired products for 6 months.The issue is now solved at zimmer biomet.According to the sales representative, the exchange of expired products is under zimmer biomet switzerland responsibility.However, the hospital has to perform its stock control of expired implants before surgeries.A complaint extract was done regarding expired product implanted: - 1 complaint (1 product), this one included, has been recorded on standard femoral stem exception -cementless- 5°42- 12/14 - right s8, reference (b)(4), from january 01, 2018 to may 26, 2021.- 1 complaint (1 product), this one included, has been recorded on standard femoral stem exception -cementless- 5°42- 12/14 - right s8, reference (b)(4), batch 0001116228.Investigation results concluded that the reported event was due to a combination of circumstances.Indeed, due to internal issues, products distribution was blocked during the past 6 months, which cause backorders and prevent the sales representative to exchange the expired products at the hospital.On the other hand, the hospital is responsible of its stock control, that implies that the hospital needs to control products expiration dates before surgeries, which was not performed in the current event.A summary of the investigation was sent to the complainant conveying proper use of the device.A summary of the investigation has been transmitted to the customer.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: STANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 542- 12/14 - RIGHT S8
• Type of Device: COATED HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11886552
• MDR Text Key: 256230041
• Report Number: 3006946279-2021-00085
• Device Sequence Number: 1
• Product Code: KXA
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2021
• Device Catalogue Number: PS126Y08
• Device Lot Number: 0001116228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 69 YR