MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. COBALT CHROME FEMORAL HEAD 542 28 / 0 / 12-14/ COL MOYEN; METALLIC FEMORAL HEAD PROTHESIS

Catalog Number P0206M28

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 12/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Associated product : bi-polar 28 cup 50mm, reference (b)(4), batch 6564377 handle in (b)(4).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

It was reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2019.Following implantation of a duo-head prosthesis with medial femoral neck fracture, the patient experienced a subluxation.On (b)(6) 2019, the doctor first attempted to re-position the implants.This was not successful.During the fluoroscopy one could see that the duo head was separated from the metal head.The outer pe snap ring was also shown as closed, so that a dislocation of the head from the duo head shell must be suspected.Subsequently, a revision procedure was performed.

Event Description

It was reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2019.Following implantation of a duo-head prosthesis with medial femoral neck fracture, the patient experienced a subluxation.On (b)(6) 2019, the doctor first attempted to re-position the implants.This was not successful.During the fluoroscopy one could see that the duo head was separated from the metal head.The outer pe snap ring was also shown as closed, so that a dislocation of the head from the duo head shell must be suspected.Subsequently, a revision procedure was performed.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g1-2, g4, g7, h2, h6, h10.Product has been sent and analyzed in united kingdom.No x-ray have been received showing the dislocation.Therefore, the reported event could not be confirmed.The product was returned and lab analysis was performed by r&d facility in united kingdom.The product analysis shows that the cocr femoral head presents a patch of light scratches on the articulating surface, as well as impact marks on the rim, which may have been caused during disassembly from the femoral stem.The acetabular cup and the polyethylene ring were received and showed no nonconformity but only scratches which could have been caused during the revision surgery.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 the biomet bi-polar cup used with the crco head was compatible.However, the compatibility with the stem could not be verified as no information has been received regarding femoral component.A complaint extract was done regarding revision due to dislocation: 7 complaints (7 products), this one included, have been recorded on cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference (b)(4), from january 01, 2017 to october 13, 2020.1 complaint (1 product), this one included, has been recorded on cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference (b)(4), batch j6464909.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.A summary of the investigation has been sent to the complainant.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: COBALT CHROME FEMORAL HEAD 542 28 / 0 / 12-14/ COL MOYEN
• Type of Device: METALLIC FEMORAL HEAD PROTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10061101
• MDR Text Key: 193297113
• Report Number: 3006946279-2020-00103
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2024
• Device Catalogue Number: P0206M28
• Device Lot Number: J6464909
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR