MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE BANTAM ACET CUP 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-044
Medical Device Problem Codes	Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hematoma (1884); Pain (1994); Loss of Range of Motion (2032); Physical Asymmetry (4573)
Date of Event	07/15/2020
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
(b)(6) year-old patient comes for a 15-day revision of the left hip prosthesis ((b)(6) 2020) for hip dysplasia, with a previous 5cm shortening, and in surgery they perform a femoral osteotomy to reduce the prosthesis.He refers from the immediate post op to presented intense pain in the left hip, which does not improve with analgesics, limits his gait and movements of the hip in total hip replacement for dysplasia, hospitalized for dislocation of the hip prosthesis, currently with traction of soft tissues with 3 kg of weight, patient who is afebrile, painless, with shortening, already scheduled for surgery.Additional information received 12/17/2020: revision note stated that the acetabular component has more than 15 degrees of anteversion and loose insert.
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.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: PINNACLE BANTAM ACET CUP 44MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11118271
• Report Number: 1818910-2021-00274
• Device Sequence Number: 11774963
• Product Code: LPH
• UDI-Device Identifier: 10603295009580
• UDI-Public: 10603295009580
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K983491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-20-044
• Device Catalogue Number: 121720044
• Device Lot Number: HZ7073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +1.5 GR; CORAIL2 STD SIZE 8; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR +4 10D 28IDX44OD; ARTICUL/EZE BALL 28 +1.5 GR; CORAIL2 STD SIZE 8; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR +4 10D 28IDX44OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male