MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 13.0; CEMENT CENTRALIZER/PLUG

Catalog Number	137622000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Impaired Healing (2378); Post Operative Wound Infection (2446)
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
Study no: (b)(6).Clinical adverse events received for infection: deep, device and procedure (relatedness).Device related: remote possibility.Procedure related: probably.Date of implant: (b)(6) 2024, date of revision: (b)(6) 2024, device location: left.Treatment/impact: revision.
Event or Problem Description
Medical records received: dor: (b)(6) 2024: patient received a left hip revision of a depuy liner and depuy femoral head to treat pain, wound drainage, and delayed wound healing secondary to deep infection.The surgeon notes the patient had a previous irrigation and debridement to treat the infection that did not ultimately treat the infection (captured on (b)(4)).Upon entering the joint infected tissue was debrided and scar tissue excised.The cup and stem were well fixed and retained.The head and liner were exchanged, and the wound was cleaned before placing antibiotic beads.The patient received depuy devices and was placed on long-term iv antibiotics.The procedure was completed without complications.The revision is considered a continuation of the infection event treated with previous i & d captured on (b)(4).As such, the revision will be captured on (b)(4).Doi: (b)(6) 2024.Doe: (b)(6) 2024 (i & d to treat infection).Dor: (b)(6) 2024: revision of head and liner to treat infection- continuation.Left 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 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.H11 additional narrative: added: b5, h6 health effect (clinical and impact code).

• Brand Name: CEMENTRALIZER 13.0
• Common Device Name: CEMENT CENTRALIZER/PLUG
• 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 ; 3035526892
• MDR Report Key: 20052135
• Report Number: 1818910-2024-17916
• Device Sequence Number: 12751436
• Product Code: JDI
• UDI-Device Identifier: 10603295034469
• UDI-Public: (01)10603295034469(17)280731(10)M43T84
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K871510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 137622000
• Device Lot Number: M43T84
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 108 KG