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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Local Reaction (2035); Reaction (2414)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided.Date implanted - (b)(6) 2013.Concomitant medical products- 00630506240 liner 62377066 (b)(6) 2013.Concomitant medical products- 00625006530 bone screw self-tapping 62483518 (b)(6) 2013.Concomitant medical products - 00625006535 bone screw self-tapping 62483026 (b)(6) 2013.Concomitant medical products - 00620005222 shell porous with cluster holes 62461277 (b)(6) 2013.

Event Description

It was reported that a patient underwent an initial right hip procedure approximately 3 years ago.Subsequently, the patient was revised due to pseudo tumor, metallosis and fluid collection.Corrosion was noted on the trunnion of the stem.The head was removed and replaced; a poly liner was implanted.There were no complications or delays reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Reported event was confirmed by review of photographs, and x-rays.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the head identified the following: there was debris in the taper.Scratches, most likely from the removal process were present on the spherical surface of the head.No other damage was noted.Sem 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 was assigned a modified goldberg score of 4.A score of 4 corresponds to damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris.No further evaluation could be performed with the returned product.Evaluation of the returned product does not change the conclusions of previous investigation.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 additional event information to report at this time.

• Brand Name: ZIMMER VERSYS FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 6215460
• MDR Text Key: 63627841
• Report Number: 0002648920-2016-04395
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2021

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: Physician
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801804002
• Device Lot Number: 62418596
• Other Device ID Number: N/A
• 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: 11/30/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 03/02/2018; 07/20/2018; 01/04/2021
• Supplement Dates FDA Received: 03/30/2018; 08/13/2018; 01/11/2021
• 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 Age: 67 YR
• Patient Weight: 56