MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-38 CUP NON FLARED SZ 58MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problems Hearing Loss (1882); Pain (1994); Toxicity (2333); Joint Dislocation (2374); Test Result (2695)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported by the patient that he underwent an initial right total hip arthroplasty on (b)(6) 2005.Subsequently, patient was revised on (b)(6) 2015 alleging pain, hearing loss, and elevated cobalt-chromium levels.The head was replaced and a poly acetabular liner added.It was further reported that the patient's hip has dislocated on (b)(6) 2015 and on (b)(6) 2015.Patient was subsequently revised on (b)(6) 2015 wherein the modular head was removed and replaced.A review of the invoice history confirmed the surgery dates.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Event Description

It was reported by the patient that he underwent an initial right total hip arthroplasty on (b)(6) 2005.Subsequently, patient was revised on (b)(6) 2015 alleging pain, hearing loss, and elevated cobalt-chromium levels.The head was replaced and a poly acetabular liner added.It was further reported that the patient's hip has dislocated on (b)(6) 2015.Patient was subsequently revised on (b)(6) 2015 wherein the modular head was removed and replaced and the acetabular liner was removed and replaced with competitor products.A review of the invoice history confirmed the surgery dates.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions.¿ this report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015- 01531 / 01532).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2015- 01531 / 01532 / 02312).

Manufacturer Narrative

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

Event Description

It was reported by the patient that he underwent an initial right total hip arthroplasty on (b)(6) 2005.Subsequently, patient was revised on (b)(6) 2015 alleging pain, hearing loss, and elevated cobalt-chromium levels.The head was replaced and a poly acetabular liner added.It was further reported that the patient's hip has dislocated on (b)(6) 2015 and on (b)(6) 2015.Patient was subsequently revised on (b)(6) 2015 wherein the modular head was removed and replaced and the acetabular liner was removed and replaced with competitor products.A review of the invoice history confirmed the surgery dates.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Additional information received from patient's legal counsel reported the patient was revised on (b)(6) 2015 due to pain.Legal counsel reported metallosis, plaque burnishing, gray fluid, and elevated metal ion levels were noted during the procedure.Subsequently, the patient underwent closed reduction procedures on (b)(6) 2015 and (b)(6) 2015 due to dislocation.The patient was revised on (b)(6) 2015 due to dislocation.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Not returned by attorney.

Event Description

Patient's legal counsel reported that patient underwent a right hip revision procedure approximately ten (10) years post-implantation due to allegations of recurrent dislocations.Legal counsel further reported that patient had previously undergone two closed reduction procedures allegedly due to dislocation.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative report received confirms patient was revised approximately ten (10) years post-implantation due to dislocations.During the procedure, a hematoma was noted.The modular head, acetabular cup and bearing were removed and replaced with a competitor cup and liner.

• Brand Name: M2A-38 CUP NON FLARED SZ 58MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4702438
• MDR Text Key: 5723344
• Report Number: 0001825034-2015-01532
• Device Sequence Number: 1
• Product Code: LZO
• 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,consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 15-106058
• Device Lot Number: 868110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2005
• 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: 70 YR
• Patient Weight: 83