MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A HI CARBON 32MM MODULAR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994); Reaction (2414)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states, ¿postoperative bone fracture and pain.¿ requested but not returned by hospital.

Event Description

It was reported that patient underwent a hip revision procedure approximately 8 years post-implantation due to pain.During the procedure, the femoral head, acetabular liner and cup were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

This follow-up report is being filed to report corrected and additional information.This report is number 1 of 2 mdrs filed for the same patient (reference 0001825034-2016-02706 & 0001825034-2017-00347).

Event Description

It was reported that patient underwent a right hip revision procedure approximately 8 years post-implantation due to pain.During the procedure, the femoral head, acetabular liner and cup were removed and replaced.Additional information received in medical records confirmed the patient¿s right hip was revised approximately 8 years post-implantation due to pain.Operative report indicates the presence of a pseudotumor, elevated metal ion levels and cystic debris.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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: M2A HI CARBON 32MM MODULAR HEAD
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5813587
• MDR Text Key: 50172554
• Report Number: 0001825034-2016-02706
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-163686
• Device Lot Number: 455440
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR