MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Bone Fracture(s) (1870); Sepsis (2067); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿a comparison of acetabular impaction grafting and trabecular metal for revision arthroplasty¿ by fiachra e.Rowan, et al, published by hip international (2016), vol, 26, no.4, pp.350-354, doi: 10.5301/hipint.5000362, was reviewed.In this retrospective comparative case-control series, the authors compare acetabular impaction bone grafting (aibg) and trabecular metal (tm) acetabular reconstruction from a single institution over a 5- to 10-year period.The aim was to determine any significant difference in radiological or clinical outcomes between both acetabular surgical revision strategies.This article focuses on acetabular reconstruction during competitor cup revision.Implanted products: the initial implants for thas were a competitor cup and liner with a charnley femoral component.If a concomitant femoral revision was indicated, either a depuy nonmodular solution stem or a depuy modular reclaim system was used.There were 2 revisions of an asr hra included within the study, assigned to the impaction bone grafting group.The reasons for cup revision included acetabular osteolysis and sepsis (4 cases).There was one periprosthetic fracture for a charnley stem that was revised.The remaining reasons for charnley stem revision (33) were unspecified instability, femoral osteolysis, and sepsis.The femoral osteolysis is attributed to the competitor polyethylene liner.Implanted products at revision were a competitor cup and liner and a depuy stem and head.Revision results: this article discusses the outcomes of revision for competitor cups and liners and will therefore not be included in this complaint.Of the stems and heads revised, 1 needed resection arthroplasty for sepsis and another was revised at another institution for unknown reasons.Captured in this complaint: 1 asr hemiarthroplasty for osteolysis and sepsis 33 charnley stems for sepsis, and unspecified instability.The authors do not attribute the joint instability to a specific product or location.The osteolysis listen in the article is attributed to the competitor polyethylene liner.33 depuy femoral heads for sepsis, and unspecified instability.The authors do not attribute the joint instability to a specific product defect or location.The osteolysis listen in the article is attributed to the competitor polyethylene liner.1 femoral stem, head, and sleeve re-revised for sepsis 1 femoral stem, head, and sleeve re-revised for unknown causes the authors provide information on page 353 in fig, 1 regarding and asr hemiarthroplasty revised for sepsis.This complaint is labeled case 1 in the guidance document.Please link that complaint to parent (b)(4).".

Manufacturer Narrative

Product complaint (b)(4).Added h6 patient code: not applicable (3189) used to capture medical device removal.Investigation summary : no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint was received into the company in the form of a literature paper with the following comment: "literature article entitled, ¿a comparison of acetabular impaction grafting and trabecular metal for revision arthroplasty¿ by fiachra e.Rowan, et al, published by hip international (2016), vol, 26, no.4, pp.350-354, doi: 10.5301/hipint.5000362.No products were received and no further product information was received.The literature paper was forwarded to clinical specialists for review.They commented: in this retrospective comparative case-control series, the authors compare acetabular impaction bone grafting (aibg) and trabecular metal (tm) acetabular reconstruction from a single institution over a 5- to 10-year period.The aim was to determine any significant difference in radiological or clinical outcomes between both acetabular surgical revision strategies.This article focuses on acetabular reconstruction during competitor cup revision.Implanted products: the initial implants for thas were a competitor cup and liner with a charnely femoral component.If a concomitant femoral revision was indicated, either a depuy nonmodular solution stem or a depuy modular reclaim system was used.There were 2 revisions of an asr hra included within the study, assigned to the impaction bone grafting group.The reasons for cup revision included acetabular osteolysis and sepsis (4 cases).There was one periprosthetic fracture for a charnley stem that was revised.The remaining reasons for charnley stem revision (33) were unspecified instability, femoral osteolysis, and sepsis.The femoral osteolysis is attributed to the competitor polyethylene liner.Implanted products at revision were a competitor cup and liner and a depuy stem and head.Revision results: this article discusses the outcomes of revision for competitor cups and liners and will therefore not be included in this complaint.Of the stems and heads revised, 1 needed resection arthroplasty for sepsis and another was revised at another institution for unknown reasons.Captured in this complaint: 1 asr hemiarthroplasty for osteolysis and sepsis 33 charnley stems for sepsis, and unspecified instability.The authors do not attribute the joint instability to a specific product or location.The osteolysis listen in the article is attributed to the competitor polyethylene liner.33 depuy femoral heads for sepsis, and unspecified instability.The authors do not attribute the joint instability to a specific product defect or location.The osteolysis listen in the article is attributed to the competitor polyethylene liner.1 femoral stem, head, and sleeve re-revised for sepsis 1 femoral stem, head, and sleeve re-revised for unknown causes the authors provide information on page 353 in fig, 1 regarding and asr hemiarthroplasty revised for sepsis.This complaint is labeled case 1 in the guidance document.Please link that complaint to parent (b)(4)." without returned parts, no further investigation of the associated products can be made.No investigation as to manufacturing defects can be made without product codes and batch numbers.Post-market surveillance is per sep-419.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9267244
• MDR Text Key: 180959261
• Report Number: 1818910-2019-111039
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention