MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problem Use of Device Problem (1670)

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Article entitled ¿functional outcome of conversion total hip arthroplasty (ctha) using uncemented distally loading femoral stem for failed fixation of proximal femoral nail - a case series¿ written by hemant h.Mathur, harsh s.Shah, and karthik vishwanathanon august 6, 2022 was reviewed.The primary objective of the study was to describe the clinical outcome of thr using an uncemented distally loading femoral stem for failure of fixation due to cephalomedullary nail in intertrochanteric hip fractures.15 patients are included within the study.All patients were implanted with a pinnacle cup with supplemental screw fixation was undertaken depending on the stability of the cup.Solution stem was implanted with a metal on polyethylene hip bearing.Complications: -six patients had slight pain postoperatively at final follow-up.No treatment indicated.-15 patients had a limp.No treatment indicated.-case number 1 ¿ 65-year-old male with a cup inclination of 37 degrees.No treatment noted.-case number 2 ¿ 67-year-old male with a cup inclination of 35 degrees and anteversion of 23 degrees.No treatment noted.-case number 3 ¿ 61-year-old female with a cup anteversion of 23 degrees.No treatment noted.-case number 4 ¿ 77-year-old male with a cup anteversion of 25 degrees.No treatment noted.-case number 5 ¿ 68-year-old female who developed intra-op hypotension, which was managed successfully with blood transfusion and vasopressor support.-case number 6 ¿ 62-year-old female with a cup inclination of 48 degrees.No treatment noted.-case number 7 ¿ 52-year-old male with a cup inclination of 35 degrees.No treatment noted.-case number 8 ¿ 40-year-old male with a cup anteversion of 28 degrees.No treatment noted.-case number 9 ¿ 55-year-old male with a cup inclination of 35 degrees and cup anteversion of 23 degrees.No treatment noted.-case number 12-68-year-old female with a cup inclination of 50 degrees and cup anteversion of 27 degrees.Patient sustained a superficial surgical site infection that was managed conservatively with culture specific intravenous antibiotics.Surgical debridement was not required, and the patient was discharged uneventfully.-case number 13 ¿ 61-year-old female with a cup inclination of 48 degrees and cup anteversion of 25 degrees.No treatment noted.-case number 15 ¿ 58-year-old female sustained a dislocation 8 days post op.Treated with a closed reduction under general anesthesia, and patient was given abduction brace for 6 weeks.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.

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: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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: 16416214
• MDR Text Key: 310347550
• Report Number: 1818910-2023-04226
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1