MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR LAT FMRL 9X137; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Separation Failure (2547)

Patient Problems Pain (1994); Scarring (2061); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 12/02/2014

Event Type  Death  

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 1 states, "material sensitivity reactions." 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 number 3 of 4 mdr's filed for the same event (reference 1825034-2014-09259, 09260, 1825034-2015-03987 and 03988).

Event Description

It was reported that patient underwent total hip arthroplasty on (b)(6) 2005.Subsequently, patient was revised on (b)(6)2014 due to patient allegations of pain, metallosis and elevated metal ion levels.It was further reported that black staining, cystic lesion, fluid, and pseudotumor were allegedly noted during the revision procedure.The patient's operative report noted soft tissue and bony destruction from metal debris and metallosis.Additional information received in operative report noted scarred abuctor tissue mass and that the head could not be disengaged from the well fixed stem.Because of this, a trochanteric osteotomy had to be performed to revove the stem.Zimmer biomet revision components were utilized along with a cable and plate to complete the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4) reported event was unable to be confirmed due to limited information received from the customer.No device or photos were received for evaluation; therefore the condition of the device is unknown.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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 multiple mdr reports were filed for this event, please see associated reports: 1825034-2014-09259, 09260, 1825034-2015-03987, 03988.

Manufacturer Narrative

This follow-up report is being filled to relay corrected and additional information.Information contained within this report has no effect on previous investigation conclusion.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.

Event Description

It was reported that the patient was revised approximately nine years post-implantation due to pain, metallosis and elevated metal ion levels.It was further reported that black staining, cystic lesion, fluid, and pseudotumor were allegedly noted during the revision procedure.The patient¿s operative report noted soft tissue and bony destruction from metal debris and metallosis.Additional information received in operative report noted scarred abuctor tissue mass and that the head could not be disengaged from the well fixed stem.Because of this, a trochanteric osteotomy had to be performed to remove the stem.Zimmer biomet revision components were utilized along with a cable and plate to complete the procedure.

• Brand Name: TAPERLOC POR LAT FMRL 9X137
• 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: 5084072
• MDR Text Key: 26035142
• Report Number: 0001825034-2015-03987
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 10/21/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 11-103203
• Device Lot Number: 852910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided; 07/13/2017; 10/20/2017
• Supplement Dates FDA Received: 11/10/2015; 08/11/2017; 10/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2005
• 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: 118