MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVE 11/13 +0; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999890340

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 09/12/2017

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

Complaint description: der states that the surgeon revised the patient by leaving the sz 48 asr cup and removing the unifemoral implant with an 11/13 taper.Update ad (b)(6) 2018 (b)(4) is reopened under (b)(4) due to receipt of asr litigation records received.Litigation alleges injury, increased chromium and cobalt levels in her blood, metallosis, excessive pseudotumor, pain and suffering, clicking sensation on her hips, loss of strength and mobility, and emotional distress.The law firm and lawyer have been updated.Added ip's for the cup and stem.Doi: (b)(6) 2009; dor: (b)(6) 2017; left hip.

Manufacturer Narrative

(b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).H6 patient code: no code available (3191) used to capture the device revision or replacement and emotional distress.

Event Description

After review of medical records, patient was revised to address complication of the total hip arthroplasty with reaction to metal debris.Patient alleges elevated metal ions.Operative notes stated of pseudotumor was superficial to the hip joint.Further dissection elevating the gluteus maximus, which was difficult secondary to the pseudotumor and loss of the normal tissue planes.Just more posterior to the greater trochanter, the patient had erosion through the external rotators.The patient had marked amount of corrosion at the trunnion, but the trunnion did not appear to be negatively affected.

• Brand Name: ADAPTER SLEEVE 11/13 +0
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7689430
• MDR Text Key: 114016885
• Report Number: 1818910-2018-64421
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K030627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 999890340
• Device Lot Number: 2745988
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR