MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE ALTRX; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 1221-36-460

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 08/21/2017

Event Type  Injury  

Event Description

Left hip periprosthetic joint infection: sequence of events as follows: indication for procedure: elderly male with failure of his left total hip arthroplasty due to aseptic loosening of the acetabular component with severe protrusio deformity.Preoperative infection workup was (b)(6).Patient continued to have significant pain and functional limitations.He was offered revision total hip arthroplasty.A few months ago, pre-operation diagnosis: failed left total hip arthroplasty due to aseptic loosening of acetabular component with protrusio deformity.Procedure performed: revision left total hip arthroplasty, acetabular component only, +modifier 22.Additional 22 modifier added due to increased complexity related to severe scarring around the hip and the protrusio deformity of the acetabular component which made explantation of his previous component quite difficult.These combined issues increases operative time by greater than 50%.Findings: failed left total hip arthroplasty due to aseptic loosening of the acetabular component with no evidence of bony ingrowth to the shell.There was substantial protrusio deformity of acetabular component through the medial wall.The intact introitus of the acetabulum made explantation difficult due to bone blocking explantation of the component.The component was ultimately able to be removed.The anterior and posterior columns remained intact indicating that the hip was suitable for hemispheric cup reconstruction.Able to achieve a stable reconstruction.The stem was stable and retained.Post op diagnosis a month later: left hip periprosthetic joint infection.Procedure performed: 1) left hip joint arthrotomy for infection with extensive irrigation and excisional debridement utilizing scalpel, electrocautery, rongeur, and curettes.2) wound vacuum-assisted closure (vac) application performed on left hip, wound size greater than 50 cm².A few days later, pre-op diagnosis: left hip periprosthetic joint infection procedure performed: 1) left total hip revision (head-liner exchange) 2) left hip irrigation and excisional debridement down to level of bone - 10cm x 18cm (180 cm²) - 11044 x 11047x8.Findings: ongoing necrotic tissue requiring further excisional debridement.Acetabular and femoral components well fixed and stable.Head and liner exchange completed without difficulty.Able to achieve a surgically clean wound following excisional debridement.Specimens: yes - explanted components removed.Depuy pinnacle neutral liner 36 x 60mm, model# 1221-36-460, lot # 676574.Stryker v40 fem head orthinox 36+5 model # 6364-2-236 , lot # g7013855.Implant(s): depuy 36mm id +4 lateralized liner, model #1221-36-4606364-2-236.Stryker v40 36mm +5 metal head, model #.20 cc stimulan beads impregnated with 2 g of vancomycin and 2.4 g tobramycin powder.

• Brand Name: PINNACLE ALTRX
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 6882137
• MDR Text Key: 86889725
• Report Number: 6882137
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2017,09/20/2017

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: No Information
• Device Model Number: 1221-36-460
• Device Catalogue Number: 122136460
• Device Lot Number: 676574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 136