MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Corroded (1131); Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Weakness (2145); Distress (2329); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Brand name, common device name, procode, lot #, part #, udi #, 510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

Pinnacle litigation records received alleging scar tissue, elevated blood cobalt levels, injury, pain, suffering and emotional distress.Update: it was stated that the primary surgery date was on (b)(6) 2008.The revision date was on (b)(6) 2019.It was also alleged that the patient suffered from joint effusion, muscle damage and muscle weakness.Doi: unknown; dor: unknown; (unknown hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: null.Device history batch: null.Device history review: null.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).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.   h10 additional narrative: added a2, a4, b5, b7 and h6(patient, device) corrected a1.

Event Description

Ppf alleges pseudotumor, metallosis and metal wear.Updated code for scar and effusion.After review of medical records patient was revised to addressed aseptic failure, left hip, status post total hip arthroplasty with metal on metal implant with subsequent metallosis.Operative findings of extensive metallosis within the synovial space with a pseudotumor forming in the area of the greater trochanter.Operative notes indicated swollen trochanteric bursa that was filled with fluid, was aspirated and sent for culture and sensitivity, removed the remaining inflammatory tissue, extensive metal staining and metallosis appearing tissue within synovial space.Femoral head was removed with extensive corrosion along the trunnion as well.Added medical history, height and weight of patient.Doi: (b)(6) 2008 dor: (b)(6) 2019 left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.X-rays provided were reviewed and found insufficient information to confirm any implant related issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed as investigation could not retrieve a lot number.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8486690
• MDR Text Key: 141031903
• Report Number: 1818910-2019-89884
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 93 KG