MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800756

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Anxiety (2328); Distress (2329); Deformity/ Disfigurement (2360); Fibrosis (3167); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation complaint received ad 7 jul 2022.Claim letter alleges breathing difficulties, very high levels of metal toxicity.Patient was revised was due to metallosis, a tumor, cysts and necrotizing tissue.Doi: 18 years ago.Dor: (b)(6) 2022.Unk 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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Event Description

Surgical pathology final report received.On (b)(6) 2022 a result was dense fibrosis with collagen necrosis, fibrin deposition, and abundant histiocytes with grayish brown pigment consistent with metallosis, rare acute inflammatory cells.Affected side is right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> update 29 july 2022: 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
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> device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

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: e1 (law firm), e3 (initial reporter occupation: lawyer), d6a, h6 ((health effect-clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b5, d6b.

Event Description

The patient was alleged to experience pain, increased metal levels in blood including cobalt and chromium, injuries, emotional distress, and disfigurement.Doi: (b)(6) 2007 dor: (b)(6) 2022 right hip.

Event Description

Medical records were received and stated the following: pfs alleges injuries on tendons, ligaments, tissues, bones within right hip.Plaintiff suffered extreme pain, trochanteric fractured, elevated metal ions, pseudotumor, metallosis and anxiety.After review of the medical records the patient was revised to address hip pain, elevated metal ions, fractured greater trochanter, pseudotumor, metallosis, trunnions and vertical cup.Operative note reported metallosis in the posterior capsule.There was fluid in the hip, trunnions in the femoral head.Pseudotumor appear to track up the iliopsoas.There was leg length discrepancy.Doi: (b)(6) 2007;dor: (b)(6) 2022; 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.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

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 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: b1 (product problem), h6 (clinical codes), h7, h9.H6 clinical code: - swelling/ edema (e2338) is used to capture swelling and edema.- unspecified tissue injury (e2015) is 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: ASR ACETABULAR CUPS 56
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15085399
• MDR Text Key: 296399950
• Report Number: 1818910-2022-13717
• 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,Followup,Followup
• Report Date: 07/22/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999800756
• Device Lot Number: 2368868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 07/29/2022; 01/03/2023; 03/08/2023; 07/06/2023
• Supplement Dates FDA Received: 07/26/2022; 08/01/2022; 01/05/2023; 03/08/2023; 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2007
• 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: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; ASR UNI FEMORAL IMPL SIZE 49; SUMMIT DUOFIX TAP SZ5 HI OFF; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 107 KG