MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A MOD HEAD STD NK; M2A ODULAR HEAD COMPNENT 32MM HEAD DIAMETER STANDARD NECK

Model Number N/A

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 15-103692 680910 universal alternative bearing shell 62mm 2-hole with screw 41 mm i.D.Taper/ porous coated, 15-105004 021690 m2a taper liner 32mm i.D.Size 41mm o.D.Taper, 103207 675870 modual taperloc femoral porous coated 13.5 x 147mm type i taper.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 03599, 0001825034 - 2017 - 03600, 0001825034 - 2017 - 03602.

Event Description

It was reported that the patient experienced pain, dislocation, metallosis, component loosening, elevated metal ion levels and lack of mobility post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.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.

• Brand Name: 32MM M2A MOD HEAD STD NK
• Type of Device: M2A ODULAR HEAD COMPNENT 32MM HEAD DIAMETER STANDARD NECK
• 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: 6610999
• MDR Text Key: 76659721
• Report Number: 0001825034-2017-03601
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/09/2017

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: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-163669
• Device Lot Number: 859270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: 12/09/2017
• Supplement Dates FDA Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2004
• 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): Other