MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL STEM 5.0X130; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Swelling (2091); Tissue Damage (2104); Reaction (2414); Ambulation Difficulties (2544)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: mri positive and cobalt chromium both elevated cobalt level 139.2 & chromium level 133.8 tissue stained dark grey, and avascular was noted to some of the tissue revision records: surgeon notes large osteolysis, and soft tissue damage as well as acetabular fractures prior to revision.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08590.0001825034 - 2020 - 03672.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 patient underwent total hip arthroplasty approximately 14 years ago.Patient underwent revision 10 years post implantation due to patient complaint of metallosis, tissue death, bone damage, lack of mobility, inflammation, metal poisoning.No further event information available at the time of this report.

• Brand Name: TAPERLOC POR FMRL STEM 5.0X130
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10613801
• MDR Text Key: 209418888
• Report Number: 0001825034-2020-03673
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

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: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 103200
• Device Lot Number: 697660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2006
• 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
• Treatment: BIOMET M2A TPR INSRT CAT#139252 LOT#186580
• Patient Outcome(s): Hospitalization; Required Intervention