MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED STD SIZE 2; HIP FEMORAL STEM

Catalog Number	101011020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hematoma (1884); Inflammation (1932); Pain (1994); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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
Medical records ad (b)(6) 2023 pertaining to non mom construct was reviewed by clinician.(b)(6) 2023 mri demonstrates right hip arthroplasty, mild increased signal on fluid sensitive sequences along the femoral stem.Moderate right greater trochanteric bursitis versus hematoma/seroma.The patient also reported having weakness and pain.The impression is mild trochanteric bursitis.Iliopsoas tendinitis appears to be from prominence of the irritating psoas tendon itself.Corticosteroid injection is recommended.Doi: (b)(6) 2022 ( stem).Doi: (b)(6) 2023 (liner, head).Doe:(b)(6) 2023.Right hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS COLLARED STD SIZE 2
• Common Device Name: HIP FEMORAL STEM
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18442485
• Report Number: 1818910-2024-00266
• Device Sequence Number: 6930159
• Product Code: MEH
• UDI-Device Identifier: 10603295380429
• UDI-Public: 10603295380429
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 101011020
• Device Lot Number: JY1387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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: ARTICUL/EZE BALL 22.225+7 NK; BI MENTUM PFRK PE LINER 22 41; PINNACLE DM LINER 48_41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female