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

Model Number N/A

Device Problems Material Erosion (1214); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Scar Tissue (2060); Tissue Damage (2104); No Information (3190)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620204822, shell, 61505877.00631004832, trilogy liner, 61320625.65771100700, stem, 61418507.00625006535, bone screw, 61436685.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 02233.

Event Description

Patient¿s legal counsel reported patient underwent left total hip arthroplasty.Legal counsel further reports patient underwent a revision procedure eight years later due to unknown reasons.Head and liner were revised.No additional information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b1, b4, b5, b6, b7, g4, h2, h6.An additional mdr report was filed for this event, please see associated report: 0001822565 - 2020 - 02841.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

It was reported patient underwent left hip revision approximately eight years post implantation due to elevated metal ions and altr.During the procedure, a pseudotumor was noted and excised, 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 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.An additional mdr report was filed for this event, please see associated report: 0001822565 - 2020 - 03300.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: the patient had elevated metal ion levels.During the revision procedure, adverse local tissue reaction and scar tissue were identified.Black ring was observed on the trunnion.Anterior impingement at 45 degrees was noted during range of motion trials prior to dislocating the hip.The head and liner were replaced with new zimmer biomet products.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.Visual examination of the returned product identified here is damage to the taper of the returned head.The head was submitted for further analysis.Analysis determined a consensus modified goldberg score of 3.A score of 3 corresponds to ¿fretting on >30% of the surface and/or aggressive local corrosion attack with corrosion debris¿ the complaint is confirmed based on the returned device and medical records.Root cause remains unchanged.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: VERSYS 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10236443
• MDR Text Key: 199654364
• Report Number: 0002648920-2020-00338
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/16/2024

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803203
• Device Lot Number: 60919187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 09/17/2020; 01/11/2024
• Supplement Dates FDA Received: 08/10/2020; 09/24/2020; 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2008
• Is the Device Single Use?: Yes
• 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 Sex: Female