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	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
The patient was revised to address painful right hip and loosening of the stem at the bone to implant interface.Replacement of pinnacle 50 x 28 metal liner and 28mm 1.5 femoral head.Acetabular liner was replaced with a pinnacle dual mobility 50 x 43 liner and a competitor femoral stem during revision surgery.Doi: 2004.Dor: (b)(6) 2021; affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Two x-ray images were provided for review.It was not possible to confirm this report or identify root cause.Nothing indicative of a product problem is identified.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 11404216
• Report Number: 1818910-2021-04202
• Device Sequence Number: 4503242
• Product Code: LPH
• UDI-Device Identifier: 10603295056874
• UDI-Public: 10603295056874
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 152021050
• Device Lot Number: X74BA1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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: ARTICULEZE M 28MM 1.5; PINNACLE MTL INS NEUT28IDX50OD; ARTICULEZE M 28MM 1.5; PINNACLE MTL INS NEUT28IDX50OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR