MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5; FEMORAL SLEEVE

Catalog Number 999800315

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

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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 records ad 29 jun 2023 alleges pain and discomfort, increased metal levels in blood including cobalt and chromium- permanent injuries, emotional distress, disability, disfigurement, economic damages including medical and hospital expenses for revision surgery followed by monitoring , rehabilitation and pharmaceutical costs.Doi: (b)(6) 2009; dor: (b)(6) 2022; affected side: right hip.

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.Update (b)(6) 2023 update received on (b)(6) 2023 did not have any additional details to be added in investigation.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.H10 additional narrative: added: b5, g4, h4 and h6 d1, d2, d4, d10.

Event Description

The patient underwent a two-stage hip revision in periprosthetic infection.

Event Description

Litigation and medical records received.Patient is uncertain when symptoms began.Sustained injuries to his tendons, ligaments, tissues and bones within his right hip.Suffered cold-like symptoms and breathing difficulties which turned into pneumonia.Doctors could not get his illness under control.Cobalt and chromium levels were elevated.Found metallosis throughout the hip and infection in hip joint.Post-revision surgery.Patient was hospitalized and had an infection.Needed to have pik line for the antibiotic to treat the infection.Uses 4-wheel walker or wheelchair to avoid fall.Has anxiety about all the damage the high ion levels and metal in the bloodstream.Patient had failed tha; metallosis; elevated cobalt & chromium levels and had his 1st revision on (b)(6) 2022 and patient had re-revision on (b)(6) 2022.( two stage revision for infection).

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 (expiration date) and h6 h6 clinical symptoms code: unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17317818
• MDR Text Key: 319017285
• Report Number: 1818910-2023-14204
• 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: 07/13/2023

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: 09/02/2013
• Device Catalogue Number: 999800315
• Device Lot Number: 2726699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 09/18/2023
• Supplement Dates FDA Received: 07/27/2023; 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2008
• 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 52.; ASR UNI FEMORAL IMPL SIZE 46.; SUMMIT POR TAPER SZ7 STD OFF.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male