MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA COCR MOD HEAD +3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 10/28/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent left total hip arthroplasty on (b)(6) 2004, and right total hip arthroplasty on (b)(6) 2006.Patient's legal counsel reported patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, elevated metal ion levels, metal poisoning and metallosis.Subsequently, legal counsel reported patient underwent left hip revision procedures on (b)(6) 2009, (b)(6) 2013, (b)(6) 2013, and (b)(6) 2013.Legal counsel for patient alleged no revision procedure to patient's right hip.This report is based on allegations set forth in patients notice and the allegations there in 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 associated deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿postoperative bone fracture and pain.¿ this report is number 8 of 10 mdrs filed for the same event (reference 1825034-2014-04137, 04139 / 04147).

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 8 of 11 mdrs filed for the same patient (reference 1825034-2014-04137, 04139 / 04147 & 2015-01850).

Event Description

Legal counsel for patient reported patient underwent left total hip arthroplasty on (b)(6) 2004, and right total hip arthroplasty on (b)(6) 2006.Patient's legal counsel reported patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, elevated metal ion levels, metal poisoning and metallosis.Subsequently, legal counsel reported patient underwent left hip revision procedures on (b)(6) 2009, (b)(6) 2013, (b)(6) 2013, and (b)(6) 2013.Legal counsel for patient alleged no revision procedure to patient's right hip.This report is based on allegations set forth in patients notice and the allegations there in are unverified.Additional information received in operative report noted patient underwent a left hip revision on (b)(6) 2009 due to pain, squeaking and crunching.Operative report noted the presence of bursal inflammation, clear synovial fluid, acetabular anteversion, migration of the acetabular cup, metallic scuff on the head, fibrinous tissue, a medial osteolytic lesion, bone loss in the anterior and posterior columns, a medical rami cyst, and no evidence of metallosis or purulence.The modular head and acetabular cup were removed and replaced.Operative report further noted a second left hip revision took place on (b)(6) 2013 due to recurrent instability and dislocations.Operative report noted the presence of a retroverted cup and bone deficiency in the acetabulum.The modular head and acetabular cup were removed and replaced with a competitor cup and a biomet head.Operative report further noted a third left hip revision took place on (b)(6) 2013 due to recurrent instability and displacement of the competitor cup.Operative report noted the competitor cup was loose and displaced from the bone posteriorly.The modular head, stem and competitor acetabular cup were removed.

• Brand Name: 28MM DIA COCR MOD HEAD +3MM 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: 3814097
• MDR Text Key: 4529577
• Report Number: 0001825034-2014-04144
• 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: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 163663
• Device Lot Number: 995920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2012
• 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: 63 YR