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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Degraded (1153)

Patient Problems Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 02/06/2017

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.510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

Pfs and medical records received.Pfs alleges pain, impaired mobility, and elevated metal ions.After review of medical records, patient was revised to address right hip pain and clicking of right hip, status post right total hip arthroplasty, metal-on-metal hip replacement, dislodgement of metal liner with significant metallosis and corrosion of the femoral neck taper.Revision notes stated of extensive scar tissue on the tensor fascia lata.A large amount of effusion, slightly turbid, which looked consistent with underlying metallosis was noticed when the short external rotator and the capsule were elevated as a flap.There was extensive metallosis all around the hip joint and the capsule.The trunnion has an extensive corrosion which was cleaned thoroughly.When the socket was exposed, it was noticed that the underlying metal liner of the socket got dislodged, and osteolysis was found towards the back of the socket.Doi: (b)(6) 2004; dor: (b)(6) 2017; (right hip).Patient is bilateral.See (b)(4) for left hip.

Manufacturer Narrative

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.Product complaint #
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> (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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 8378159
• MDR Text Key: 137410649
• Report Number: 1818910-2019-86026
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 109