MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRODIGY SM STAT LNG RT 13.5MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number	152021050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
Unf and medical records received.After review of medical records, the patient was complaining of hip pain, then the patient for adverse local tissue reaction of right metal-on-metal total hip arthroplasty.Operative findings reported that there is a large amount of straw-colored fluid of approximately 8 ml that was aspirated.On entry into the deep fascia, there was overall large pseudotumor formation.There is a large amount of fatty infiltrate along her posterior capsule insertions.There is loss of abductors of at least 25% of the gluteus minimus.There is a large cystic formation anterior and anterolateral along her proximal femur.There is necrotic debris in the cystic formation.When the femoral head was removed, there is a small ring of black precipitate on the cobalt chrome head.It should be noted that the stem is also cobalt.So, again significant loss of soft tissue structures with fatty infiltrate along posterior necrosis and fatty infiltrate along the abductors and a large cystic formation anteriorly with loss of abductors, quadriceps, and anterior structures.Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip.
Additional 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.H10 additional 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: 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.

• Brand Name: PRODIGY SM STAT LNG RT 13.5MM
• Common Device Name: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9720632
• Report Number: 1818910-2020-05123
• Device Sequence Number: 367211
• Product Code: LPH
• UDI-Device Identifier: 10603295056874
• UDI-Public: 10603295056874
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 152021050
• Device Lot Number: BE7AK1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR