MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN METAL-ON-METAL HIP; PROSTHESIS, HIP

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint- (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and 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.This report is being submitted late as it has been identified in remediation.Literature: robinson, e., "cross-sectional imaging of metal-on-metal hip arthroplasties" (2014).Acta orthopaedica 2014, vol.85 (6).Doi 10.3109/17453674.2014.964618.

Event Description

Information was received based on review of a journal article titled, "cross-sectional imaging of metal-on-metal hip arthroplasties: can we substitute mars mri with ct?¿ which attempts to determine whether ct is a suitable substitute for mars mri in evaluation of the painful mom-ha.The journal article reports adverse events identifying evidence of moderate or severe muscle atrophy was present to varying extents in forty-nine of fifty patients with unexplained hip pain.It is unknown which hip system the patients that experienced the adverse events listed above received.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN METAL-ON-METAL HIP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7054155
• MDR Text Key: 92799171
• Report Number: 0001825034-2017-10539
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2014
• 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