MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL 9X137; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Tissue Damage (2104); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03788.0001825034 - 2020 - 03789.0001825034 - 2020 - 03790.

Event Description

It was reported a patient had an initial left tha.Subsequently, the patient was revised approximately 11 years later due to metallosis, pain, ho, elevated metal ion levels, altr, scar tissue, and tissue damage.The head and the taper adapter were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, the stem was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the stem was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: TAPERLOC POR FMRL 9X137
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10683599
• MDR Text Key: 211469074
• Report Number: 0001825034-2020-03791
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K830313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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 Model Number: N/A
• Device Catalogue Number: 103203
• Device Lot Number: 273930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention