MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 1 PC SHELL 38MMX50MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Metal Related Pathology (4530)

Event Date 06/24/2015

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 1 states, "material sensitivity reactions." number 15 states, ¿elevated metal ion levels have been reported with metal-on-metal articulating surfaces.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03662 / 03663).

Event Description

It was reported a patient enrolled in a clinical study underwent right total hip arthroplasty on (b)(6) 2010.Subsequently, patient was revised on (b)(6) 2015 due to pain caused by an adverse reaction to metal debris and elevated metal ion levels.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.A conclusive root cause of the event could not be determined.

Event Description

There is no additional event information available at the time of this report.

Manufacturer Narrative

Supplemental report provided as additional information was received pertaining to the patient identifier (a1) and implant placement date in d6a sections updated a1 b4 g3 g6 h2 h6: implant code, clinical code and device code h10 sections corrected d6a.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The additional information does not change the outcome 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

There is no update to the prior event description provided.

• Brand Name: M2A 1 PC SHELL 38MMX50MM
• Type of Device: PROSTHESIS, KNEE
• 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: 5011997
• MDR Text Key: 23382640
• Report Number: 0001825034-2015-03662
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 15-105050
• Device Lot Number: 032560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2009
• 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; Hospitalization; Required Intervention; Required Intervention
• Patient Sex: Female
• Patient Weight: 105 KG