MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM PF CUP 56ODX50ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Compatibility Problem (2960); Insufficient Information (3190)

Patient Problems Debris, Bone Shedding (1803); Reaction (2414); No Information (3190)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum pf cup 58odx52id/ pn us157858/ ln 300550, m2a-magnum 52-60mm tpr ins std/ pn 139268/ ln 661850.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location being unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03853.

Event Description

It was reported that patient underwent right hip revision approximately seven years post implantation due to unknown reasons.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.Concomitant medical products - m2a-magnum mod hd sz 50 mm/ pn 157450/ ln 098350, taperloc por red/dist 15.0x150/ pn 12-103208/ ln 521850, m2a-magnum 42-50 mm tpr insrt-3/ pn 139254/ ln 636380.

Event Description

It was reported that patient was revised approximately seven years post implantation due to acetabular loosening, bone loss, and metallosis.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Reported event was confirmed through review of medical records.There are warnings in the package insert that these types of events can occur and associated risks are addressed in risk documentation.Device history report was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A conclusive 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.

Event Description

Additional information received in revision operative report indicated slightly grayish fluid within the joint, metal staining in the synovium, gross loosening of the acetabular component, and bone deficiencies of the acetabulum.The femoral stem was noted to be well fixed.The femoral head and acetabular cup were removed and replaced and a polyethylene liner was implanted.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: M2A-MAGNUM PF CUP 56ODX50ID
• 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: 6652980
• MDR Text Key: 77927981
• Report Number: 0001825034-2017-03854
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 798254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2006
• 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; Required Intervention
• Patient Age: 66 YR