MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. EXCEPTION STANDARD STEM CEMENTED LEFT SIZE 2; HIP, PROTHESIS

Catalog Number PS125002

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Ossification (1428)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated devices avantage reload cup ti ha s48, reference p0460p48, batch 0000803673, avantage e1 inlay s48 / 22,2, reference p0560e48, batch 0000822612, cocr femoral head d22,2/ 12-14/ -2/ s, reference p0206c22, batch 00j2970687, refobacin bone cement r 40x1, reference 3003940001, batch 136eaa3012, optiplug 10mm, reference 4361, batch 200849b, (b)(6).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

It was reported that a patient was reviewed during follow-up visit for retrospective study on the exception cemented stems.It was therefore found that patient suffered from femur cortical hypertrophy of zone 5-6 without implant loosening.The hypertrophy was seen on x-ray.No symptoms either pain were found.No treatment was provided.

Event Description

It was reported that a patient was reviewed during follow-up visit for retrospective study on the exception cemented stems.It was therefore, found that patient suffered from femur cortical hypertrophy of zone 5-6 without implant loosening.The hypertophy was seen on x-ray.No symptoms either pain were found.No treatment was provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.X-rays before and after surgeries have been received.It can be noticed on the x-ray of the left hip before implantation that the femur seems to have a normal size.On the contrary, on the x-ray showing both hips 10 years (for right hip) and 7 years (for left hip) after implantation, an hypertrophy of the femur around the distal part of the stem can be noticed.The surgical notes of the initial left hip arthroplasty has been reviewed and did not show any incident during the procedure.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 review of the raw material certificate shows no non conformity or deviation.A complaint extract was done regarding femur cortical hypertrophy: - 1 complaint (1 product), this one included, has been recorded on standard femoral stem exception -cemented- 5°42- 12/14 - left s2, reference ps125002, from (b)(6) 2017 to (b)(6) 2021.- 1 complaint (1 product), this one included, has been recorded on standard femoral stem exception -cemented- 5°42- 12/14 - left s2, reference ps125002, batch 0000652828.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: EXCEPTION STANDARD STEM CEMENTED LEFT SIZE 2
• Type of Device: HIP, PROTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11116295
• MDR Text Key: 225046498
• Report Number: 3006946279-2021-00001
• Device Sequence Number: 1
• Product Code: JDI
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: PS125002
• Device Lot Number: 0000652828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 53