MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 28IDX44OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-28-144
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	08/15/2020
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
It was reported that the original surgery was performed on (b)(6) 2020.The patient ended up having a dislocation and a closed reduction was performed.Unfortunately, the patient had another dislocation, the second time, and was unable to reduce the hip.The surgeon decided to revise the patient's acetabular component though he felt that the positioning of the cup was appropriate.He also felt that maybe the patient was possibly dislocating due to the small size of the components.A 44 mm cup was removed, the bone was reamed up to 47 and a 47 mm bimentum cup was implanted.This allowed them to increase the size of the femoral head which helped with the patient's stability.A 28 mm +1.5 ts ceramic head was used inside the bimentum poly and ran through a final range of motion.It was found to be satisfactory and the patient was closed up.No surgical delay noted.Doi: (b)(6) 2020, dor: (b)(6) 2020, right hip.
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.

• Brand Name: ALTRX +4 10D 28IDX44OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10476141
• Report Number: 1818910-2020-19145
• Device Sequence Number: 2792956
• Product Code: LPH
• UDI-Device Identifier: 10603295015987
• UDI-Public: 10603295015987
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2020

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: 1221-28-144
• Device Catalogue Number: 122128144
• Device Lot Number: J63D99
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: DELTA CER HEAD 12/14 28MM +1.5; PINN BANTAM W/GRIPTION 44MM; PINN CAN BONE SCREW 6.5MMX25MM; DELTA CER HEAD 12/14 28 MM +1.5; PINN BANTAM W/GRIPTION 44 MM; PINN CAN BONE SCREW 6.5 MMX25 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR