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

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Ossification (1428); Unspecified Infection (1930)

Event Date 08/12/2021

Event Type  Injury  

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.

Event Description

Article entitled "total hip arthroplasty with ultra-short uncemented stem in patients with osteonecrosis of the femoral head: mid-term results" written by libor necas, maros hrubina, marian melisik, juraj cabala, zoltan cibula, and matej daniel published by hip international on august 12, 2021 was reviewed.The aim of this study is to assess clinically and radiographically a series of our patients who had undergone primary tha with the proxima stem for the treatment of onfh, and who were followed for minimum of 5 years.97 hips (73 patients) were involved in the study.All were implanted with proxima stem, pinnacle cup, ceramic head, and ceramic liner.Adverse event involving depuy ¿ synthes products: radiographic findings ¿ 1mm radiolucent line in one cup with no noted progression (asymptomatic).26 hips were in varus position or had migrated/subsided with no intervention noted 2 hips were noted to be loose.1 of the loose hip was noted to have migrated with pain.Both patients declined interventions so loosening wasn't confirmed via revision.4 hips were noted to have radiolucent lines ¿ no intervention noted.Heterotopic ossification was noted in 8 patients (one was noted to be (b)(6) years-old, but doesn't provide any more information regarding the patient) ¿ no intervention noted other adverse events.1 patient had an early infection (2 weeks post op) and underwent an i&d with antibiotics 1 patient had instability/dislocation 2 months after surgery.The proxima stem was revised to a higher offset.1 patient had a squeezing phenomenon 3 years after surgery.Patient was pain-free and satisfied.No treatment noted.

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 device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12681376
• MDR Text Key: 277890394
• Report Number: 1818910-2021-23232
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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: 10/11/2021

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
• 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: 10/11/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/02/2021
• 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