MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA COCR MOD HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Fragmentation (1261); Metal Shedding Debris (1804)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Swelling (2091); Synovitis (2094); Toxicity (2333); Osteolysis (2377)

Event Date 03/04/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported patient underwent a left total hip arthroplasty on (b)(6) 2000 and a right total hip arthroplasty on (b)(6) 2003.Legal counsel reports patient allegations of pain and swelling.Subsequently, patient underwent a left revision procedure on (b)(6) 2004 due patient allegations of pain, swelling, fragmentation of the acetabular cup, metal debris, heterotopic bone formation and femoral head and liner wear.It was reported the modular head, liner and acetabular cup were removed and replaced.Legal counsel reported patient allegations of pain in both hips in 2008.Subsequently, patient underwent a left hip revision on (b)(6) 2014 due to patient allegations of osteolysis, acetabular cyst, synovitis, metallosis, degenerated and necrotic synovium and focal foreign body giant cell reaction.The modular head, liner, and acetabular cup were removed and replaced.Legal counsel further reports patient allegations of metal poisoning.This report is based on allegations set forth in plaintiff'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 11 states, "wear and/or deformation of articulating surfaces." number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is number 4 of 5 mdrs filed for the same event (reference 1825034-2014-04358 & 04474 / 04477).

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

Patient's legal counsel reported patient underwent a left total hip arthroplasty on (b)(6) 2000 and a right total hip arthroplasty on (b)(6) 2003.Legal counsel reports patient allegations of pain and swelling.Subsequently, patient underwent a left revision procedure on (b)(6) 2004 due patient allegations of pain, swelling, fragmentation of the acetabular cup, metal debris, heterotopic bone formation and femoral head and liner wear.It was reported the modular head, liner and acetabular cup were removed and replaced.Legal counsel reported patient allegations of pain in both hips in 2008.Subsequently, patient underwent a left hip revision on (b)(6) 2014 due to patient allegations of osteolysis, acetabular cyst, synovitis, metallosis, degenerated and necrotic synovium and focal foreign body giant cell reaction.The modular head, liner, and acetabular cup were removed and replaced.Legal counsel further reports patient allegations of metal poisoning.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received in patient operative (op) notes dated (b)(6) 2004 reports femoral head wear, evidence of metal and poly wear, fluid in capsule, and a fractured and fragmented acetabular component.The cup and head were removed and replaced.Op report dated (b)(6) 2014 notes patient underwent a second revision on the left side due to pain, metallosis, supra-acetabular cyst, and synovial fluid.The cup and head were removed and replaced.

• Brand Name: 28MM DIA COCR 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3824992
• MDR Text Key: 20020257
• Report Number: 0001825034-2014-04477
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/02/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 163662
• Device Lot Number: 037340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2003
• 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: 66 YR