MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122128046
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient had been dislocating and had a minor infection since discharge from the original implant on may 1.The patient had a deep inferior femoral fracture about two years prior and had been living without a functioning joint until (b)(6) 2024.The patient was 58mm short at the initial implant and soft tissues were extremely tight, possibly aiding in dislocation.Dr.Accessed that the stem was in good version, well-fixed, and at good leg length.Dr.Accessed that the cup was in good inclination and version.The neutral liner was exchanged for a +4 10 deg liner and the +1.5 head was changed for a + 5 ts head due to soft tissue lactation over the last month.There were no complaints from the surgeon or staff and no delay in or time.Doi: on (b)(6) 2024, dor: on (b)(6) 2024, affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.Was there any patient harm/consequence related to the event? negative.Patient was well positioned and adjusted for tension and length at initial surgery date.Soft tissues laxed over the course of the month and a larger offset head was needed to compensate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: altrx neut 28idx46od.Product code: 122128046.Lot number: m33z30.Manufacturing date: 27-apr-2023.Expiry date: 31-mar-2028.Quantity manufactured: (b)(4).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 : product description: altrx neut 28idx46od.Product code: 122128046.Lot number: m33z30.Manufacturing date: 27-apr-2023.Expiry date: 31-mar-2028.Quantity manufactured: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device [lot m33z30] number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: ALTRX NEUT 28IDX46OD
• 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 46581-0988 ; 3035526892
• MDR Report Key: 19648991
• Report Number: 1818910-2024-14427
• Device Sequence Number: 15391230
• Product Code: LPH
• UDI-Device Identifier: 10603295015932
• UDI-Public: (01)10603295015932(10)M33Z30(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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 Catalogue Number: 122128046
• Device Lot Number: M33Z30
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 07/11/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/05/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 28MM +1.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female