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); Pain (1994); Anxiety (2328); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 11/18/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation papers allege pain, injury, and elevated metal ion levels.Update rec¿d (b)(6) /2015 - plaintiff¿s preliminary disclosure form was received, which identified dob information.Part/lot information was identified from patient sticker sheet.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: (b)(6) 2015.Litigation complaint received ad (b)(6) 2023.Update ad (b)(6) 2023 litigation records received.Litigation records alleges emotional distress, disability, disfigurement and economic damages.Added account name, associated contacts, concomitant products and dor.Corrected patient initials and doi.Doi: (b)(6) 2008.Dor: (b)(6) 2023.Right hip.

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, h6 (clincal code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: patient claimed any physical injuries as a result of the device.He was uncertain as to when the symptoms began.He sustained physical injuries to his tendons, tissues and bones within his right hip.Suffered extreme pain, agitation, anxiety and panic attacks over the past 10 to 15 years.He suffered skin rashes on his legs, arms and scalp.Suffered severe pain in his lower back, right buttock and groin because of his hip.Suffered elevated cobalt and chromium levels.During revision procedure, physician found metallosis throughout his hip.Post-revision surgery, his right leg is now one and a half inches shorter than his left leg.He has to use cane to ambulate.The ongoing gait problems are causing back issues.He is unable to do activities without any sever pain in the hip area.It is difficult to walk for any length of time.He has stress and anxiety about all the damage that the asr has caused and about future damage that the high ion levels and metal in his bloodstream can cause.

• 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
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17468919
• MDR Text Key: 320481864
• Report Number: 1818910-2023-16006
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 999800312
• Device Lot Number: 2499570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2015
• 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
• Treatment: ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT POR TAPER SZ8 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male