MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. STANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 542- 12/14 - RIGHT S7; PROTHESIS, HIP

Catalog Number PS126Y07

Device Problem Osseointegration Problem (3003)

Patient Problem Ossification (1428)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated products: cobalt chrome femoral head 5°42 ø28 / -3.5 / 12-14 / col court, reference p0206c28, batch 0000684452.Avantage reload acetabular cup / cementless / size 54, reference p0460p54, batch 0000660953.Avantage e1 insert size 54 ø 28, reference p0561e54, batch 0000673373.The received x-ray showed that the bone around the lower part of the stem is overdeveloped for the right hip.Therefore, the reported event is confirmed.The device will not be returned to the manufacturer.Therefore it will not be analyzed.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 conclusions or information, a supplemental will be filed accordingly.

Event Description

The patient is part of a clinical study.On (b)(6) 2020, the surgeon finally provided delayed study data.It was reported that the patient suffers from cortical hypertrophy in zones 3 and 5 since (b)(6) 2016.According to the surgeon, the adverse event is possibly related to the procedure and definitely related to the stem.

Event Description

The patient is part of a clinical study.On 22-april-2020, the surgeon finally provided delayed study data.It was reported that the patient suffers from cortical hypertrophy in zones 3 and 5 since (b)(6) 2016.According to the surgeon, the adverse event is possibly related to the procedure and definitely related to the stem.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Received x-ray shows a bone excrescence at the lower part of the stem which correspond to the hypertrophy mentioned in the event.The product analysis can't be performed as the product was not returned the device manufacturing quality record indicate that the released product met all requirements to perform as intended.The instructions for use have been reviewed and it was found that all the devices used were compatible.A complaint extract was done regarding cortical hypertrophy: 2 complaints (2 products), this one included, have been recorded on exception standard femoral stem right size 7, reference ps126y07, from january 01, 2017 to september 23, 2020.1 complaint (1 product), this one included, has been recorded on exception standard femoral stem right size 7, reference ps126y07, batch 0000636989.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.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 S7
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10027762
• MDR Text Key: 194038930
• Report Number: 3006946279-2020-00100
• 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: study
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: PS126Y07
• Device Lot Number: 0000636989
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 85