MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM OFFSET COCR MOD HD +6MMNK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Frayed (1262); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 06/09/2014

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 (b)(6) 2003.Legal counsel for patient reported patient underwent a right revision procedure on (b)(6) 2006 due to patient allegations of pain, swelling, and inflammation.Legal counsel for patient further reports that patient underwent a further right revision procedure on (b)(6) 2012 due to patient allegations of pain, inflammation, lack of mobility, elevated metal ion levels, metallosis, fretting and corrosion.Legal counsel also reported that patient underwent a further right hip revision procedure on (b)(6) 2013 due to unspecified complications.There has been no reported left hip revision procedure to date.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information provided in patient medical records indicates right total hip arthroplasty was performed on (b)(6) 2003.Additional information provided in patient medical records indicates right hip revision performed on (b)(6) 2006 was due to pain and subluxation.The patient¿s operative report noted decreased anteversion of cup and femoral component, synovitis, and dark staining.Additional information provided in patient medical records indicates right hip revision performed on (b)(6) 2012 was due to pain.The patient¿s operative report noted possible adverse metal ion/adverse soft tissue, and synovial irritation.Additional information provided in patient medical records indicates right hip revision performed on (b)(6) 2013 was due to pain.The patient¿s operative report noted suspected anterior irritation due to anterior osteophytes and impingement of femur.Review of invoice history confirmed an additional right hip revision performed on (b)(6) 2014.Additional information received noted that on (b)(6) 2012 and (b)(6) 2014 patient¿s blood was tested.

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.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 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.¿ number 10 states, "fretting and crevice corrosion can occur at interfaces between components." number 11 states, ¿wear and/or deformation of articulating surfaces.¿ number 14 states, ¿postoperative bone fracture and pain.¿ this report is number 4 of 4 mdrs filed for the same patient (reference 1825034-2014-04409 and 07609 / 07611).

Manufacturer Narrative

(b)(4).This follow up report is being submitted to relay additional information.Concomitant products - part: ep-105780 name: epoly 32mm +5 rglc lnr hw sz22 lot: 437280.The investigation is still in process.Once the investigation is complete a follow up mdr report will be submitted.Multiple mdr reports were filed for this event.Please see associated reports:0001825034-2017-06385.

Event Description

It was reported that a patient was revised due to unknown reasons.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the received components confirms the report of a revision.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: 32MM OFFSET COCR MOD HD +6MMNK
• 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: 4077402
• MDR Text Key: 4826064
• Report Number: 0001825034-2014-07611
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK914675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 163544
• Device Lot Number: 677140
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2004
• 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: 58 YR