MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY ACETABULAR SHELL WITH HOLESW

Catalog Number 0062005820

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/11/2014

Event Type  Injury  

Event Description

It is reported that the patient was revised due to loosening and a broken screw.

Manufacturer Narrative

Evaluation summary: primary operative notes describe placing a 58 cut with one screw which had excellent purchase.Revision notes state that the acetabular component was grossly loose with abundant fluid within the joint and an inflammatory reaction with no signs of infection.Extremely out of focus images of the removed implants were provided, which do not show any obvious bone on-growth on the porous surface of the shell.X-rays were provided and a radiolucent line is seen outlining the acetabular shell, most prominently in the distal half of the shell.It also appears that the shell may have been placed in an abduction angle higher than that recommended in the surgical technique.With the information provided, a definitive root cause cannot be stated.Evaluation codes: review of the device history records did not find any deviations or anomalies.It is not suspected that the product failed to meet specifications.The information on this form was previously submitted under manufacturing report #1822565-2014-00733.

Manufacturer Narrative

This follow up report is being submitted to report additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The additional event details received do not change the root cause previously reported.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 was revised approximately six (6) years post-implantation due to acetabular component loosening, pain, difficulty ambulating and osteolysis.Primary operative notes describe placing a 58 cup with one screw which had excellent purchase.Revision notes state that the acetabular component was grossly loose with abundant fluid within the joint and an inflammatory reaction with no signs of infection.

Manufacturer Narrative

The follow-up report is being submitted to relay additional and/or corrected information.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.

Event Description

It was reported patient was revised approximately six (6) years post-implantation due to acetabular component loosening, pain, difficulty ambulating and osteolysis.No additional information is available.

• Brand Name: TRILOGY ACETABULAR SHELL WITH HOLESW
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715 0261
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715 0261
• Manufacturer Contact: p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4531961
• MDR Text Key: 5353931
• Report Number: 2648920-2015-00037
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2018
• Device Catalogue Number: 0062005820
• Device Lot Number: 60955609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: 02/26/2018; 05/28/2019; 10/30/2019
• Supplement Dates FDA Received: 03/05/2018; 06/21/2019; 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CATALOG #00625006540; ZIMMER SELF-TAPPING BONE SCREW; LOT #60786333
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75