MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL

Catalog Number UNK HIP FEMORAL HEAD METAL

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Date 07/09/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer (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

Ppf and medical records received.Ppf alleges infection.After review of medical records, patient was revised to address failed right total hip arthroplasty, metal-on-metal reaction, and pseudotumor.Revision notes stated of a large psudotumor which was visible as the skin incision was made and dissection was carried down to level of the fascia.The hemostasis was obtained using electrocautery.Cultures were taken and sent to pathology.Doi: (b)(6) 2007 (liner, head, stem, and cup) - dor: (b)(6) 2012; (right hip).This pc is for the second revision of the right hip.Please see (b)(4) for first revision and (b)(4) for third revision.

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.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 : 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).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.Replaced surgical intervention with device revision or replacement.

Event Description

Pfs alleges metallosis, infection following revision with multiple procedure to removed tissue and clean infection.In addition to what were previously reported in the medical records the patient was revised due to hip pain.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9268092
• MDR Text Key: 164722960
• Report Number: 1818910-2019-113695
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP 52 MM; APEX HOLE ELIMINATOR; NEUTRAL METAL INSERT 36 MM; PRODIGY LARGE STATURE 12 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 66