MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Joint Dislocation (2374)

Event Date 04/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00771100710 ¿ m/l taper stem ¿ 60765902, 00630505032 ¿ xlpe liner ¿ 61106334, 00620005222 ¿ trilogy shell - 61126612, 00625006530 ¿ bone screw ¿ 61010553, 00625006520 ¿ bone screw ¿ 61026687.Customer has indicated that the product will not be returned to zimmer biomet for the investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01662, 0002648920-2020-00258.

Event Description

It was reported that patient underwent a left hip revision approximately 6 years post implantation due to pain, elevated metal ion levels, instability, and dislocation.During the revision, altr was apparent in the joint capsule along with corrosion on the taper with black discoloration and a ring of black corrosion debris.The head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting patient underwent a hip revision due to pain, instability, dislocation and elevated metal ion levels.Evidence of corrosion at the taper junction related to altr was noted in the capsule.There was cloudy, grayish, straw-colored fluid expressed from the joint.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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 MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10032197
• MDR Text Key: 190116936
• Report Number: 0002648920-2020-00257
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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: 10/25/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 61111778
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention