MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY CUPS; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Scar Tissue (2060); Patient Problem/Medical Problem (2688)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00771300700 ¿ m/l taper stem ¿ unknown lot; 00801803202 ¿ cocr head ¿ 62480002; 00784801300 ¿ m/l taper neck ¿ 62458886; 00631005032 ¿ liner - 62483455.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow up will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00222, 0001822565-2020-01320.

Event Description

It was reported that patient underwent a right hip revision approximately 7 years post implantation due to pain and elevated metal ion levels.During the procedure, altr was noted due to corrosion of the neck-stem taper.The shell was also noted as being malposition, but was left intact.All other 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.Reported event was confirmed by review of medical records noting that during the revision procedure, corrosion was observed between the femoral neck and distal stem's taper.The head was not removed from the neck; therefore, the neck-head junction was not inspected.An extended osteotomy was performed to remove all femoral components and the neck and head were removed attached to each other.Altr and scar tissue were present in the joint.The acetabular component was in a very horizontal and overly anteverted position.This was compensated for by a polyethylene insert inside the acetabular component with a 20mm lip placed anterior and slightly inferior.This reduced the anteversion of the cup somewhat but was still very horizontal.The shell had a solid ingrowth and was securely fixed.The head, liner, stem, neck, and a bone screw were removed and new zimmer biomet products were implanted.No other complication/ significant findings were noted.Dhr was reviewed and no discrepancies were found.The additional information does not change the outcome of the 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.

• Brand Name: TRILOGY CUPS
• 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: 10038635
• MDR Text Key: 190335001
• Report Number: 0002648920-2020-00262
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• 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: 08/03/2020

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: 10/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 00620005222
• Device Lot Number: 62498666
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/03/2020
• 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