MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: riemer k, lange j.Early periprosthetic hip joint infection managed by cementless one-stage revision - a case series.J bone jt infect.2022 feb 25;7(1):43-50.Doi: 10.5194/jbji-7-43-2022.Pmid: 35251904; pmcid: pmc8892566.Objective and methods: the purpose of this study is to evaluate the effectiveness of cementless one-stage revision for early periprosthetic joint infection (pji) in elective primary total hip arthroplasty (tha) regarding risk of re-operation with exchange of implants in 18 patients between january 2012 and march 2018.Early pji is defined as confirmed infection within 6 weeks of primary tha with clinical signs of fever, erythema, wound drainage, and pain, lab results of elevated crp, leukocytosis, and positive cultures, and direct fistulation (deep infection) to the joint.All stage 1 revisions followed the coriha protocol requiring extensive biofilm debridement during revision, drape and instrumentation changes, patient re-sterilization between removal and implantation, and no use of drains or pain catheters.All patients retained their revision devices by end of follow-up.Non-patient specific results: the authors do no provide sufficient information to associate these events with one of the identified patients.3 patients with primary infectious agents s.Aureus had delayed wound healing treated with i&d.The wound was healed within 6 months.1 patient had an unspecified ppf at 1 month and again at 2 years, both requiring orif.No revision required.Patient specific results: patient 1: 63 yo female, bmi 39.7.Primary implants: competitor cup/liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: corynebacterial.Iv/oral antibiotics: yes.Revised with competitor cup/liner paired with depuy corail stem and depuy unknown head.Patient 2: 52 yo male, bmi 49.2.Primary implants: pinnacle gription cup/unknown liner paired with corail stem/unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle gription cup/unknown liner and corail stem/unknown head.Patient 3: 78 yo female, bmi 33.4.Primary implants: competitor cup/liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: mrsa.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 4: 77 yo female, bmi 32.2.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: mixed flora.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 5: 72 yo female, bmi 27.5.Primary implants: competitor cup/liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: unspecified.Iv/oral antibiotics: yes.Revised with: pinnacle gription cup/unknown liner and corail stem/unknown head.After revision, patient had prolonged wound healing requiring a i&d, all products were retained.Patient 6: 72 yo female, bmi 30.9.Primary implants: competitor cup/liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with competitor cup/liner paired with depuy corail stem and depuy unknown head.Patient 7: 73 yo male, bmi 28.1.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: unspecified.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 8: 44 yo female, bmi 41.2.Primary implants: pinnacle gription cup/unknown liner paired with corail stem/unknown head.Intraoperative culture: mrsa.Iv/oral antibiotics: yes.Revised with: pinnacle gription cup/unknown liner and corail stem/unknown head.Patient 9: 58 yo male, bmi 32.6.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 10 76 yo male, bmi 29.3.Primary implants: pinnacle gription cup/unknown liner paired with competitor stem/head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: depuy pinnacle cup/unknown liner and competitor stem/head.Patient 11: 82 yo male, bmi 27.2.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle gription cup/unknown liner and corail stem/unknown head.Patient 12: 72 yo female, bmi 17.2.Primary implants: pinnacle gription cup/unknown liner paired with competitor stem/head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle gription cup/unknown liner and corail stem/unknown head.Patient 13: 78 yo female, bmi 21.5.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: unspecified.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 14: 76 yo female, bmi 27.7.Primary implants: pinnacle gription cup/unknown liner paired with competitor stem/head.Intraoperative culture: s.Aureus, gas.Iv/oral antibiotics: yes.Revised with: depuy pinnacle cup/unknown liner and competitor stem/head.Patient 15: 63 yo female, bmi 42.0.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 16: 68 yo male, bmi 31.2.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.Patient 17: 67 yo male, bmi 44.6.Primary implants: pinnacle gription cup/unknown liner paired with competitor stem/head.Intraoperative culture: p.Multocida, cons.Iv/oral antibiotics: yes.Revised with primary implants: pinnacle gription cup/unknown liner paired with competitor stem/head.After revision, the patient experienced prolonged wound healing (15 months) and lle edema attributed to possible venous damage during revision combined with comorbidities of hypertension, venous insufficiency, and a.Fib.Treatment was and i & d and anticoagulant therapy.Patient 18: 81 yo female, bmi 25.4.Primary implants: pinnacle cup/unknown liner paired with depuy corail stem and depuy unknown head.Intraoperative culture: s.Aureus.Iv/oral antibiotics: yes.Revised with: pinnacle cup/unknown liner and corail stem/unknown head.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• 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: 14873863
• MDR Text Key: 295030844
• Report Number: 1818910-2022-12034
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention