MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM PF CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Necrosis (1971); Pain (1994); Local Reaction (2035); Reaction (2414)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

The complaint number corresponding to this medwatch is (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant product(s): - unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02357 & 0001825034-2017-02359.

Event Description

It was reported by legal counsel that the patient alleged to mom post-implantation.No additional information provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.

Manufacturer Narrative

The product was not returned, nor were photos provided.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.

Manufacturer Narrative

This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient 's right hip was revised approximately 9 years post implantation due to pain, discomfort, adverse local tissue reaction to right hip.

Manufacturer Narrative

The following report is submitted to relay additional information 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.

Manufacturer Narrative

The following report is submitted to relay additional information.Concomitant medical products: 157450, m2a-magnum mod hd sz 50mm, 819330; 139254, m2a-magnum 42-50mm tpr insrt-3, 931740; x180311, bi-metric/x por nc 11x135, 942340.Reported event was unable to be confirmed as no medical records were provided.Customer indicated that the product is not available to be returned and the product location is unknown.Dhr review was performed no deviations or anomalies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with operatives notes provided.Revision operative notes for the right hip demonstrated that the patient was revised due to adverse tissue reaction.There was massive bony erosion noted on the radiographs.Massive altr with necrotic greater trochanter and entire proximal femur as well as remaining acetabular bone.Significant necrosis of the entire abductor mechanism.Femoral head removed without complication, no wear or corrosion noted on the trunnion.Well-fixed and well-aligned acetabular component and femoral stem.Review of the device history record identified no deviations or anomalies would contribute to reported event.Additional information does not affect the root cause.Root cause could not be determined with information available.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: M2A MAGNUM PF CUP
• 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: 6464340
• MDR Text Key: 71885578
• Report Number: 0001825034-2017-02359
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 815290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention