MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ADAPTER SLEEVES 12/14 +2; FEMORAL SLEEVE

Catalog Number 999800312

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

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)

Event Date 08/18/2022

Event Type  Injury  

Event Description

Litigation complaint received, patient underwent a revision due to severe pain and discomfort, increased metal levels in blood including cobalt and chromium; permanent injuries, emotional distress, disability, disfigurement; economic damages.Doi: (b)(6) 2008.Dor: (b)(6) 2022.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.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.

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.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 sustained physical injuries in his tendons, ligaments, tissues and bones within his right hip.Patient suffered from pressure in his right hip and intermittent discomfort.Suffered elevated cobalt and chromium levels as well as trunnionosis.Surgeon informed the patient to have revision.During revision, surgeon found metallosis throughout the hip and also osteolysis.Patient experience some persistent weakness and stiffness and clicks when walking.Patient have anxiety about the damage that the asr caused and future damage that the high ion levels and metal in his bloodstream.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: ADAPTER SLEEVES 12/14 +2
• Type of Device: FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17435183
• MDR Text Key: 320140427
• Report Number: 1818910-2023-15686
• 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,Followup
• Report Date: 08/01/2023

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: 08/18/2013
• Device Catalogue Number: 999800312
• Device Lot Number: 2723412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 09/26/2023; 10/11/2023
• Supplement Dates FDA Received: 10/10/2023; 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2008
• 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 58.; ASR UNI FEMORAL IMPL SIZE 51.; SUMMIT POR TAPER SZ6 STD OFF.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL STEM SUMMIT.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male