MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: 2016.Concomitant medical products: 00784801300 modular neck unknown, item #: unknown unknown liner lot #: unknown, item #: unknown unknown stem lot #: unknown, item #: unknown unknown cup lot #: unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00628.

Event Description

It was reported that patient underwent a total hip arthroplasty.The patient was revised due to pain approximately five years later.The joint fluid was black and there was a large presence of metallosis found everywhere.The trunnion of the ml kinectiv neck had worn down, the femoral head fell off.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6 complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A versys femoral head and a modular neck were returned for evaluation.As returned, the conical taper of the head exhibits dark debris and a thread like pattern.The modular neck shows burnishing on the elliptical taper.Material is missing from the conical taper, including the surface that contains the etch detail that shows the lot number.A versys femoral head was submitted for further analysis.Analysis determined: the taper of the returned device was reviewed via optical microscopy.The taper was assigned a modified goldberg score of 3.A score of 3 corresponds to fretting on greater than 30 percent of the surface and/or aggressive local corrosion attack with corrosion debris.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL HEAD STERILE PRODUCT 12/14 TAPER
• 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: 11445453
• MDR Text Key: 244800630
• Report Number: 0002648920-2021-00051
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801804002
• Device Lot Number: 61424892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/01/2021
• 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