MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122140056
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on about (b)(6) 2023, the patient developed dress syndrome following the revision and developed a fever and more drainage and was hospitalized.On (b)(6) 2023, the patient had a revision left total hip with irrigation and debridement and placement of antibiotic spacer with antibiotic beads to address infected left total hip.During the surgery, the surgeon observed clear bone disease from the patient¿s underlying mom failure with dead bone of the greater trochanteric region with no abductors, which was also seen during the previous revision from (b)(6) 2023.The femoral bone appeared to be harboring chronic osteomyelitis and there was micro fracturing around the greater and lesser trochanter as the bone was extremely paper thin.The cup, screw, liner, head, and stem were removed.Possible osteomyelitis was observed.It was also noted that gauge wires were used to hold bone fragments in position.Medical records note that the components removed were de puy products along with competitor components were implanted during this procedure.Doi: (b)(6) 2023; dor: (b)(6) 2023; affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A search of the medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<122140056>/lot combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > a search of the medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<122140056>/lot combination.

• Brand Name: ALTRX NEUT 40IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21147454
• Report Number: 1818910-2025-00777
• Device Sequence Number: 15727634
• Product Code: LPH
• UDI-Device Identifier: 10603295393344
• UDI-Public: (01)10603295393344(17)280430(10)M3464P
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 122140056
• Device Lot Number: M3464P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Male