MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET BIPOLAR PROSTHESIS; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Problem (1384); Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Reaction (2414)

Event Date 06/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products ¿ biomet m2a magnum cup, catalog#: us157852, lot#: 454850.Biomet bi-metric stem, catalog #: x180312, lot#: 767540.There are warnings in the package insert that these types of events can occur.Under possible adverse effects, number 1 states, "material sensitivity reactions.Implantation of foreign material in tissues may result in histological reactions involving various sizes of macrophages and fibroblasts." and, "particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid." number 10 states, "fretting and crevice corrosion may occur at interfaces between components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records found no evidence of product nonconformance.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.

Event Description

Legal counsel for patient reported the patient underwent a right hip revision nine years post-implantation due to metal-on-metal complications.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Medical records indicate the patient was revised due to pain, instability and clicking from the joint, elevated metal ion levels and unspecified mechanical symptoms.Revision operative report notes metallosis, grey-staining and metallic-staining of the capsule, staining of the proximal femur trunnion, and proximal femur osteolysis.The femoral head and taper adapter were removed and replaced and a dual mobility bearing was implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified: a m2a-magnum mod hd sz 46mm, part # 157446 from lot 545290, was returned and evaluated against the complaint.Visual inspection found the head to scuffed and worn consistent with metal on metal construction.Tool marks were observed around the rim corresponding to the location of tool marks observed on the adapter.A m2a-magnum 42-50mm tpr insrt-3, part # 139254 from lot 708220, was returned and evaluated against the complaint.Visual inspection found scratching on the exposed face of the adapter.Tool marks were observed around the rim corresponding to the location of tool marks observed on the rim of the head.Visual examination of the conical taper of the m2a magnum taper adapter (lot 708220) shows damage in the form of dark debris and burnishing / scuffing.Reference photos.Additional information does not change the root cause of the previous investigation.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.

Event Description

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

• Brand Name: BIOMET BIPOLAR PROSTHESIS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6407252
• MDR Text Key: 70015039
• Report Number: 0001825034-2017-01577
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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: Physician
• Device Expiration Date: 06/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 545290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: 08/16/2017; 12/18/2020
• Supplement Dates FDA Received: 09/15/2017; 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR