MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products : 00625006525, bone scr 6.5x25 self-tap, 62332465.The 00625006525, bone scr 6.5x25 self-tap, 62256249.The 00771101100, femoral stem 12/14 neck taper, 62063430.The 00630505036, liner standard 3.5 mm offset 36 mm, 82280309.Unknown, unknown cup, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient left hip revision approximately three years post-implantation due to pain, trunnionosis, metallosis, and elevated metal ion levels.During the revision, yellow fluid, no evidence of discoloration or metallosis, no evidence of wear of poly, stable stem, and discoloration of trunnion were noted.The femoral head and poly liner were revised.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The complaint was confirmed based on the surgical op notes that were provided.Device history records reviewed and identified no deviations or anomalies that could contribute to the reported event.A definitive root cause cannot be determined with the information 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: COCR FEMORAL HEAD
• 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: 7299872
• MDR Text Key: 101056513
• Report Number: 0001822565-2018-01108
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953337
• 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,Followup
• Report Date: 05/14/2018

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: 12/05/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 62240858
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2012
• 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: 60 YR
• Patient Weight: 71