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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Wound Dehiscence (1154); Pain (1994); Tissue Damage (2104); Discomfort (2330)

Event Date 12/02/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: rd118858 591260 m2a 38mmx58mm cup, 11-103207 477490 taperloc lat pc 13.5mm t1.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 - 02479.

Event Description

It was reported by patient¿s legal counsel that patient¿s right hip was revised approximately 10 years post-implantation due patient allegations of pain, discomfort, soreness, notations of metallic stained tissue, dehiscence of the posterior hip implant capsule, and elevated levels of cobalt and chromium.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported by patients legal counsel that the patient was revised approximately ten years post-implantation due to metallic stained tissue, dehiscence of the posterior hip implant capsule, and elevated levels of cobalt and chromium.Medical records noted brown gray material within the joint and throughout the tissue, bone loss around the acetabulum, muscles around the joint were damaged and loose.It was also noted that the patient had large cavity bone defect.Debridement was performed.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional and corrected information.The reported event is confirmed.No product was returned; the visual and dimensional evaluations could not be performed.Device history record (dhr) review identified no discrepancies.Review of the primary op notes dated (b)(6) 2004 indicates that the patient underwent an initial right tha procedure due to degenerative joint diseases for the right hip.During the procedure surgeon noted patient had severe articular cartilage disease with subchondral sclerosis in the femoral head and eburnated acetabulum.Surgeon also noted patient had large cavity bone defect.Revision operative findings show surgeon noted massive amount of a brown gray material within the joint itself which is very poor quality tissue, also dark brown/gray fluid through the tissue and bone loss surrounding about 50% of the acetabulum implant.Surgeon also noted patient had large cavity bone defect.Surgeon performed bone grafting behind the cup.A definitive root cause for the reported event could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 38MM MOD HD STD NK
• 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: 6491408
• MDR Text Key: 72778067
• Report Number: 0001825034-2017-02480
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2017

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: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-173662
• Device Lot Number: 623440
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 09/18/2017
• Supplement Dates FDA Received: 08/11/2017; 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2004
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR