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

Model Number N/A

Device Problems Corroded (1131); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02311.0001825034 - 2021 - 02313.

Event Description

It was reported a initial right total hip arthroplasty performed.Legal notification received of unknown complications and indicate a possible revision has occurred approximately six (6) years post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues metallosis, pain, infection, corrosion, elevated ion levels, and wear debris.No complications were noted during the revision.A definitive root cause cannot 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.

Event Description

It was reported the initial right total hip arthroplasty performed.Legal notification received patient developed right hip pain, and underwent testing with concern for septic hip and elevated metal ions.Patient underwent revision 16 years post implantation of head/liner, along with i&d performed.Surgeon note capsule had frank pus and metal debris, along with corrosion.Cultures performed revealed mssa and was treated with iv antibiotics.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

An investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

• Brand Name: M2A 38MM MOD HD STD NK
• Type of Device: PROSTHETIC, 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: 12301183
• MDR Text Key: 265820554
• Report Number: 0001825034-2021-02312
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 11-173662
• Device Lot Number: 068330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2005
• 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: 36 YR
• Patient Sex: Female