MAUDE Adverse Event Report: ZIMMER, INC. TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Disability (2371)

Event Date 05/13/2008

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Concomitant products ¿ versys hip system femoral head p/n 00801804003 l/n 60535884; trilogy acetabular system longevity crosslinked polyethylene liner p/n 00630506440 l/n 60498314; zimmer hip system xl taper stem p/n 00992202018 l/n 60077821; zimmer cable cerclage p/n 00223200418 l/n 60535884; zimmer shell porous p/n 00620206420 l/n 60679171; zimmer neck taper p/n 00992308340 l/n 60529476.Multiple mdr reports were filed for this event.Please see associated reports: 0002648920-2017-00364, 0001822565-2017-03703, 0001822565-2017-03704.

Event Description

It was reported that patient underwent a left hip revision one year post-implantation due to a failed hip arthroplasty which included varus deformity of left femur, ankyloses of left hip with massive heterotopic ossification.The operative report noted that a corrective osteotomy was performed.The liner, head, and stem were removed and replaced.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.According to the revision surgery operative notes radiographs showed the lateral placement of the stem of the femur laterally and posteriorly.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.

• Brand Name: TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6609307
• MDR Text Key: 76589626
• Report Number: 0001822565-2017-03703
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: Physician
• Device Expiration Date: 06/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 00630506440
• Device Lot Number: 60498314
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2006
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR