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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Local Reaction (2035)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown stem, unknown liner, unknown cup.Event was initially reported on 0001825034-2019-00036.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03250.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient was revised due to elevated metal ions.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  a femoral head was returned.Visual evaluation of the head identified the following: there was debris in the taper.Scratches, nicks, and gouges, most probably from the removal process were present on the spherical surface.No other damage was noted.Further analysis revealed the following: the taper of the returned device was reviewed via optical microscopy (magnification range 5x - 50x) using a keyence vhx-1000 digital microscope.The taper had damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris.Device history record was reviewed and no discrepancies were found.Root cause was 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.

Event Description

No further event information available at the time of this report.

• Brand Name: COCR HEADS
• 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: 10533004
• MDR Text Key: 206960059
• Report Number: 0002648920-2020-00413
• Device Sequence Number: 1
• Product Code: JDI
• 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: 02/04/2021

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 Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801804003
• Device Lot Number: 61092952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 98