MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TPR HI CARBON 41/32MM LNR; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(6).This report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2016-00010 / 00184 / 03196).

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.A patient was identified in the article that underwent total left hip arthroplasty.Subsequently, pain, discomfort, elevated metal ions, increased cup inclination angle and cup anteversion were reported.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device was not returned so no product evaluation could be conducted.This device was used for treatment.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified 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.

• Brand Name: M2A TPR HI CARBON 41/32MM LNR
• 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: 5890835
• MDR Text Key: 52606813
• Report Number: 0001825034-2016-03196
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 61