MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 32 MM I.D.; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 3 to 4 weeks post implantation of a total hip arthroplasty, the patient presented with pain.The patient was taken back to the operating room for a hip revision, where the acetabular liner and femoral headball were revised.Unusual wear and some defects were reportedly noted on the liner.The surgeon was not sure if this was from some bone remaining in the acetabular liner or another issue.There were no surgical complications.No additional information was available.
Additional Manufacturer Narrative
(b)(4).D6a: (b)(6) 2024.D10: cat# 650-1160 lot# 3087123 delta cer fem hd 32/+6mm t1.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately 6 weeks post implantation of a right total hip arthroplasty, the patient began having increased right sided hip pain.Laboratory work did not indicate any infection, but given the severity of the symptoms, almost 20cc of fluid was aspirated from the hip joint which also proved to be negative.This led the surgeon to believe that there was a problem with the articulating surface, and subsequently, the patient was revised.At that time, it was noted that there was obvious polyethylene scarring and linear consistent with a possible third body.The patient has responded well, and the symptoms are improving.Cultures at the time of surgery were also negative.No additional information available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was returned and evaluated.Visual examination of the returned product identified that the polar boss, anti-rotation scallops, rim face, and elevated rim showed gouges and deformation damage.Scratches were noted to the etched face.The inner spherical surface had damage and wear from use, which included indentations and deformation marks.The inner spherical surface was rough and uneven.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.The reported liner product was reviewed for compatibility with the femoral head, with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review, the complaint was confirmed.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 LONGEVITY LINER 20 DEGREE ELEVATED RIM 32 MM I.D.
• Common Device Name: PROTHESIS, 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19418581
• Report Number: 0002648920-2024-00168
• Device Sequence Number: 19636890
• Product Code: LPH
• UDI-Device Identifier: 00889024125599
• UDI-Public: (01)00889024125599(17)280710(10)66070648
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00632005632
• Device Lot Number: 66070648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 09/26/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/11/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female