MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TI LOW PROFILE SCREW 6.5X35MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 01/22/2014

Event Type  Injury  

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.The following sections could not be completed because the part/lot information could be: catalog number - 103534, lot number - 099150, expiration date - dec 31, 2022, manufacture date ¿ jan 3, 2013.Or the part/lot information could be: catalog number - 103532, lot number - 925500, expiration date - dec 31, 2022, manufacture date ¿ dec 7, 2012.Or the part/lot information could be: catalog number - 103537, lot number - 049440, expiration date - dec 31, 2022, manufacture date ¿ jan 3, 2013.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 4 states, "loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 6 states, " inadequate range of motion due to improper selection or positioning of components." number 9 states, "fatigue fracture of component may occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." number 10 states, "fretting and crevice corrosion may occur at interfaces between components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 5 of 6 mdrs filed for the same patient (reference 1825034-2016-00763 / 00767 and 3002806535-2016-00095).Not returned by attorney.

Event Description

Legal counsel for patient reported the patient underwent a right total hip arthroplasty on (b)(6) 2005 and a left total hip arthroplasty on (b)(6) 2005.Subsequently, patient's legal counsel reported the patient underwent a revision procedure on left side on (b)(6) 2013 due to patient allegations of audible noise, elevated metal ion serum levels and fluid collection.The medical records indicated metal staining, synovitis and bone damage were present.The femoral head and acetabular cup were removed and replaced.Patient's legal counsel further reported the patient underwent a revision procedure on the left side on (b)(6) 2014 due to patient allegations of pain and fractured screw.The medical records indicated loosening of the acetabular cup and a piece of the fractured screw was retained.The femoral head, acetabular liner and screws were removed and replaced.Subsequently, patient's legal counsel reported the patient underwent a revision procedure on the right side on (b)(6) 2014 due to patient allegations of audible noise, elevated metal ion serum levels, fluid collection, pain and limited mobility.The medical records indicated trunnionosis, black debris and synovitis were present.The femoral head was removed and replaced with an acetabular liner and femoral head.Patient's legal counsel further reported patient underwent a revision procedure on the right side on (b)(6) 2015 due to unknown reasons.The femoral head was removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 6 of 8 mdrs filed for the same patient (reference 1825034-2016-00330 / 00763 - 00767 & 3002806535-2016-00050 / 00089).

Event Description

It was reported by patient's legal counsel patient was revised on the left side approximately ten months post-implantation due to allegations of pain and fractured screws.The femoral head, acetabular liner and screws were removed and replaced.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Operative records received reports during the procedure, evidence of loosening of the cup, a piece of the fractured screw was retained by the patient, and fluid were noted.Radiographic records received reports the patient had evidence of pain and necrosis.

Manufacturer Narrative

Medical devices: 15-106058 m2a-38 cup non flared sz 58mm 093100; 11-173663 m2a 38mm mod hd +3mm nk 760400; 106064 ran/bur rnglc shl 64mm sz 26 146090; x11-170318 integral/xlat por profile 18mm 013210; 650-1055 cer bioloxd option hd 28mm 471530; 15-106060 m2a-38 cup non flared sz 60mm 363220; 650-1067 cer option type 1 tpr 1 519180; ep-200144 act artic e1 hip brg 2 178850; 650-1058 cer bioloxd option hd 1 895910; 650-1067 cer option type 1 tpr 1 937940; 31-323230 3.2mmx30mm rnglc+ acet 1 490140; ep-108426 e-poly 40mm +3 maxrom 1 825480; x11-170318 integral/xlat por prof 1 162970.Reported event was confirmed by review of the provided xrays and revision op notes.The op report noted the cup was found to be grossly loose and one screw found to be broken.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: TI LOW PROFILE SCREW 6.5X35MM
• 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: 5486854
• MDR Text Key: 39928293
• Report Number: 0001825034-2016-00767
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• 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: 64 YR