MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SUMMIT

Catalog Number UNK HIP FEMORAL STEM SUMMIT

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Depression (2361); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Th patient was revised due to groin pain and elevated ion levels.Removal asr acetabulum.Doi: unknown , dor: (b)(6)2021, (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Litigation records received.In addition to what previously alleged, records alleges discomfort, emotional distress, disability, disfigurement and economic damages.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.----------------------------------------------- update 24-jun-2022 update 23 jun 2022 received 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
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> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Medical records received.After a review of the medical records patient was revised due to failed right total hip arthroplasty secondary to metallosis and acetabular component recall.Operatives notes indicated significant cloudy fluid encountered within the trochanteric bursa, as well as within the joint itself and there was diffuse metallic staining of the synovial layer within the joint.There was some metallic debris at the base of the trunnion as well.

Event Description

Pfs alleges elevated metal ions, chronic hip and lower back pain, impaired sleep and emotional distress.During revision surgeon found some cloudy fluid, diffuse metallic stain and metallic debris in the hip.Injuries and illnesses are continuing.

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 and stated the following: pfs alleges elevated metal ion, metallosis, pseudotumor, chronic hip and lower back pain, sleep difficulties.Noted during revision as per surgeon there were significant cloud fluid, diffuse metallic staining, metallic debris in the hip plaintiff suffered uncomfortable, achy, cramp in groin and leg.Plaintiff also alleges anxiety, stress and depression.Doi: (b)(6) 2007; dor: (b)(6) 2021; 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12615421
• MDR Text Key: 275895159
• Report Number: 1818910-2021-22577
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/30/2021

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 Catalogue Number: UNK HIP FEMORAL STEM SUMMIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 06/24/2022; 07/21/2022; 09/15/2022; 06/14/2023
• Supplement Dates FDA Received: 10/20/2021; 06/24/2022; 07/21/2022; 09/24/2022; 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASR +5 ADAPTOR; ASR 54 MM ACET; ASR HEAD 47 MM; UNK HIP FEMORAL STEM SUMMIT; ASR +5 ADAPTOR; ASR 54 MM ACET; ASR HEAD 47 MM; UNK HIP FEMORAL STEM SUMMIT
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 39 KG