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 Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

(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

"literature article entitled "a minimum of 15-year results of cementless total hip arthroplasty using a 28-mm metal-on-metal articulation" written by chan-woo park, md, joo-hwan kim, md, seung-jae lim, md, young-wan moon, md, youn-soo park, md published by the journal of arthroplasty published online/accepted by publisher 4 mar 2020 was reviewed.The purpose of this study was to evaluate the clinical and radiographic outcomes of the previously reported cohort at a minimum follow-up of 15 years.The original cohort consisted of 171 primary thas (167 patients) using a 28-mm mom articulation performed between april 2000 and march 2002.Of these, 130 hips (126 patients) were reviewed at an average follow-up of 17.1 (range, 15-18) years.Clinical score, complications, presence of osteolytic lesion, serum metal ion concentrations, and implant survivorship were evaluated.X-ray images can be found on page 3 of article.It is noted 25 deaths occurred that were initially involved in the study, however, there is no indication or allegation a depuy product was the cause or contributed to any of the indicated deaths.The reason for the deaths is not indicated in the study.Depuy products: ultima cementless cup, s-rom cementless stem, unnamed metal-on-metal head and liner, and s-rom sleeve.There is no indication of any revision involving the s-rom sleeve.Adverse events: 9 patients are identified by age and gender.8 of the 9 underwent revision operations.The ninth patient has not undergone a revision operation.Case 1: male.(b)(6) years old.Revision to address infection and edema.Within one year post-primary.Cup, liner, head, and stem revised.Case 2: female.(b)(6) years old.Revision to address dislocation, groin pain, osteolysis, necrosis, and alval.Cup, liner, and head revised.Case 3: male.(b)(6) years old.Revision due to joint infection and edema.Cup, liner, head, and stem revised 2+ years after primary.Case 4: female.(b)(6) years old.Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval.Cup, liner, and head revised.Case 5: female.(b)(6) years old.Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval.Cup, liner, and head revised.Case 6: male.(b)(6) years old.Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval.Cup, liner, and head revised.Case 7: female.(b)(6) years old.Revision due to groin pain, osteolysis, elevated metal levels, and alval.Cup, liner, and head revised.Case 8: male.(b)(6) years old.Revision due to aseptic stem loosening and necrosis.Stem and head revised.Case 9: male.(b)(6) years old.X-ray imaging revealed osteolysis.No revision.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Images within the journal article have been reviewed.Nothing indicative of a product problem is identified.It is not possible to determine a root cause for the problems reported with the provided images.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.

• 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: 11109001
• MDR Text Key: 225311562
• Report Number: 1818910-2021-28185
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR