MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. EXCEPTION VAR STEM LEFT SIZE 4; HIP PROSTHESIS

Catalog Number PV125Y04

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Pain (1994); Subluxation (4525)

Event Date 05/03/2017

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to pain and subluxation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).(b)(6).Concomitant medical products: item (b)(4); lot#2016080307; item name: delta cer fm hd 036/+4mm 12/14.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Product was not returned or pictures not provided.Visual device evaluation could not be performed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.This device is used for treatment.Medical records were reviewed and show that the stem was instable which necessitated the revision.During the initial surgery, it has been noticed during first testing that the acetabulum component was instable and so was changed intraoperatively.After that, the whole prothesis was stable.A definitive root cause cannot be determined.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 VAR STEM LEFT SIZE 4
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16031792
• MDR Text Key: 305974904
• Report Number: 3006946279-2022-00127
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03599870086919
• UDI-Public: (01)03599870086919(17)210911(10)0001158789
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2021
• Device Catalogue Number: PV125Y04
• Device Lot Number: 0001158789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 107 KG