MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PRODIGY SM STAT LNG RT 13.5MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number	152021050
Medical Device Problem Codes	Degraded (1153); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Injury (2348); Test Result (2695); No Code Available (3191)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Litigation alleges patient had pain and the ability to perform normal activities has been impaired after asr hip implant.Doi: (b)(6) 2006 (left hip).Dor: (b)(6) 2017.Patient is resident of (b)(6).Update 08/28/2012 litigation papers received.They are the same papers used to create this complaint file.Update 2/1/2013 - asr/supplemental information received.Part/lot information was updated.There is no new information that would change the outcome of the investigation.
Additional Manufacturer Narrative
(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H6 patient code: no code available (3191) used to capture the emotional distress and device revision or replacement.
Event or Problem Description
After review of the medical records the patient was revised to address pain.Operative note reported consistent with a local tissue response and fluid collection in line with an adverse mom reaction.There was an osteolytic fracture of the trochanter but abduct sleeve was intact and some evidence of corrosion on the trunnion.Doi: (b)(6) 2006: dor: (b)(6) 2017; right hip.

• Brand Name: PRODIGY SM STAT LNG RT 13.5MM
• Common Device Name: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7263444
• Report Number: 1818910-2018-53250
• Device Sequence Number: 11218461
• Product Code: LPH
• UDI-Device Identifier: 10603295056874
• UDI-Public: 10603295056874
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K000207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2018

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 Expiration Date: 01/05/2011
• Device Catalogue Number: 152021050
• Device Lot Number: AA5GB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018; 06/18/2018; 07/07/2020
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 02/12/2018; 06/29/2018; 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; SMARTSETMV MV ENDURANCE 40 G; SMARTSETMV MV ENDURANCE 40 G; UNKNOWN HIP IMPLANT (CABLE); UNKNOWN HIP IMPLANT (CABLE); UNKNOWN HIP IMPLANT (CABLE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR