MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problems Pain (1994); Sepsis (2067); Test Result (2695); No Code Available (3191)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: no device was received.Root cause undetermined.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.(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, ¿the effect of acetabular inclination on metal ion levels following metal-on-metal hip arthroplasty¿ by andrew r.Emmanuel, mrcs, et al, published by the journal of arthroplasty (2014), vol.29, pp.186-191, was reviewed.The authors aim to determine whether inclination angle correlates with ion levels in arthroplasties using the articular surface replacement (asr) system.Patients undergoing asr arthroplasties had blood metal ion levels and radiograph analysis performed a mean of 3.2 years after surgery.Implanted products: 80 asr resurfacing and 213 asr-xl thas with an unknown stem.Results: during the study, there were 24 revisions for pain and elective revision for patient dissatisfaction following asr recall.There was one revision for infection that progressed to sepsis.These 24 revisions were not included in the study.The remaining patients had blood metal ions drawn and progressive radiological studies done to determine cup inclination as it related to elevated blood metal ions.The authors do not give specific information regarding blood metal ions.The range for co was 1-3619 nmol/l and cr 2-1994 nmol/l, both reach the reportability standard of 7 ppb.The total number of patients who reached the reportability standard are unknown.The range for cup inclination was 5-72 degrees, the median inclination angle was 49 degrees.The total number of mispositioned cups was not given.None of the hips studied required surgical intervention or revision surgery.None of the mispositioned cups were confirmed intraoperatively.The 25 revisions were excluded from the study and did not have metal ion levels drawn.The authors do not indicate which system was associated with the reasons for revision.This complaint includes the revisions excluded from the study and the components associated with the adverse events listed in the study.There was no information regarding intraoperative findings for the revisions performed.Captured in this complaint: asr resurfacing- 1 for sepsis and 24 for pain and mispositioned cup and elevated blood metal ions.Asr-xl- 1 for sepsis and 24 for pain and mispositioned cups and elevated blood metal ions unknown stem for pain, sepsis, and elevated blood metal ions.".

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9288684
• MDR Text Key: 165379337
• Report Number: 1818910-2019-111666
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention