MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD STD NK; HIP PROSTHESIS

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Renal Failure (2041)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to remaining in patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Patient is approximately (b)(6) years of age.Concomitant product(s): us157852, m2a-magnum pf cup 52odx46id, 199420; 13-103206, taperloc por red/lat 12.5x145, 543160.Report source, consumer - attorney.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04747.

Event Description

It was reported that patient underwent a hip revision surgery approximately 6 months post implantation due to pain and popping sound.Approximately 11 years post revision, patient was diagnosed with renal failure caused by high levels of chromium released into patient's bloodstream.Attempts have been made and no further information has been provided.

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.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause could not 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

No further event information available at the time of this report.

• Brand Name: M2A 38MM MOD HD STD NK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7785404
• MDR Text Key: 117190689
• Report Number: 0001825034-2018-04748
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 11-173662
• Device Lot Number: 155890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR