MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800312

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 07/19/2017

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.Concomitant med products: asr uni femoral impl size 47 hip asr femoral head; asr acetabular cups 54 hip asr acetabular cup; adapter sleeves 12/14 +2 hip asr femoral sleeve/augment; tri-lock bps sz 4 hi offset hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.

Event Description

The patient was revised to address metallosis.Update (b)(6) 27 aug 2018: (b)(4) has been re-opened under (b)(4) due to receipt of asr litigation record.In addition to what was previously alleged, litigation alleges injury, excessive levels of chromium and cobalt, pain, suffering, and emotional distress.Doi: (b)(6) 2008; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

(b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.

Manufacturer Narrative

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.H6 patient code: no code available (3191) used to capture the device revision or replacement.

Event Description

After review of the medical records, the patient was revised to address the right hip metallosis with asr implants.Revision note indicated that the trochanteric bursa was hypertrophic, dusky, and gray appearing consistent with metallosis and metallic tinged fluid and grayish tint to the synovium.There was a small metallic pseudotumor within the soft tissue along the gluteus maximus and vastus lateralis and scar tissue from the posterior capsule.A significant amount of trunnionosis and corrosion at the neck was also indicated.

• Brand Name: ADAPTER SLEEVES 12/14 +2
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7895157
• MDR Text Key: 120906088
• Report Number: 1818910-2018-69943
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2013
• Device Catalogue Number: 999800312
• Device Lot Number: 2631024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; TRI-LOCK BPS SZ 4 HI OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 75