MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHETIC, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item# 00620205022 | item name shell porous with cluster holes 50 mm | lot #61315203; item# 00631005032 | item name liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells | lot #61294026.The device will not be returned for analysis as location is unknown; 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: 0001822565 - 2021 - 00505.

Event Description

It was reported that initial right tha.Patent was subsequently revised 11 years later due to elevated metal ion levels, altr, pain, necrosis, in-vivo corrosion, and pseudocapsule.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0002648920-2020-00325.

Event Description

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0002648920-2020-00325.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11404843
• MDR Text Key: 234450597
• Report Number: 0001822565-2021-00506
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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: 00801803202
• Device Lot Number: 61322963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/26/2021
• 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
• Patient Weight: 68