MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS INTERCALARY SEGMENT 55MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number	1987-09-055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Article entitled "is a single dose of preoperative antibiotic therapy effective for patients treated with megaendoprosthesis after metastatic bone tumour resection?" written by m.Kiran, j.Alsousou, n.Dalal, p.Ralte, g.Kumar, and b.Kapoor published by musculoskeletal surgery on december 16, 2020 was reviewed.The aim of our study was to present the results of a single dose of preoperative antibiotic administered during anaesthetic induction in a consecutive cohort of patients undergoing mpr for metastatic bone disease (mbd).51 patients were included in this study who underwent primary megaendoprosthetic replacement (mpr) for mbd between august 2012 and september 2018.All patients were implanted with depuy lps.The exact implants implanted were not noted.35 patients were implanted with a proximal femoral replacement.7 patients were implanted with a distal femoral replacement.4 patients were implanted with a proximal humeral replacement.3 patients were implanted with a distal humeral replacement.2 patients were implanted with a total femoral replacement.Adverse events: one case of superficial wound infection which resolved with two weeks of oral clindamycin.One case of deep infection in a proximal humeral replacement performed for metastasis from a malignant melanoma.The patient¿s scar had healed, and he was progressing well under the care of the physiotherapists.He presented with warmth and redness along the surgical scar for a period of two days, three months after the initial surgery.A debridement and implant retention procedure was performed with exchange of modular parts.Patient received oral and iv antibiotics for the treatment of the infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: LPS INTERCALARY SEGMENT 55MM
• Common Device Name: LPS AND S-ROM : KNEE ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14186267
• Report Number: 1818910-2022-07280
• Device Sequence Number: 20074114
• Product Code: JWH
• UDI-Device Identifier: 10603295078616
• UDI-Public: 10603295078616
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 1987-09-055
• Device Catalogue Number: 198709055
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown