MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 43; HIP FEMORAL HEAD

Catalog Number 999890243

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation record received.Litigation alleges pain, emotional distress, limitation of activities, loss of enjoyment of life, elevated metal ions, injuries, and adverse local tissue response secondary to metal on metal articulation along with metallosis and blackened tissue.Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 25 march 2021.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b7, d4 (lot #, expiration date and udi), d10, h4 and h6 (clinical codes).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased and injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, a2 (age), d1, d2a, d4 (catalog), g1 and h6 (impact and device codes).

Event Description

Xrays and bone scan indicate loosening of the acetabular component.Revision notes stated that the it band was scarred in very thin.There was some hip capsule but no external rotators viable.There was a little bit of bloody fluid but no significant fluid.There was significant uncovering of the cup superiorly and posteriorly and had thin acetabular wall.Metallosis debris and tissue around the capsule was excised.Patient had instability and soft tissue damage.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 43
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7400083
• MDR Text Key: 104527263
• Report Number: 1818910-2018-56782
• 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: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 999890243
• Device Lot Number: 2312400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 48; SUMMIT DUOFIX TAP SZ4 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR