MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX66OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-466

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised due to infected hip; surgeon explanted components, and implanted prostalac spacer.Doi: (b)(6) 2020; dor: (b)(4).Left hip.

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, sterilization or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ALTRX +4 NEUT 40IDX66OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10853663
• MDR Text Key: 216667062
• Report Number: 1818910-2020-24828
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295393559
• UDI-Public: 10603295393559
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Model Number: 1221-40-466
• Device Catalogue Number: 122140466
• Device Lot Number: J36A47
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 11/13 S-ROM 40MM M SPEC+12; ALTRX +4 NEUT 40IDX66OD; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MULTIHOLE W/GRIPTION 66MM; S-ROM*SLEEVE PRX ZTT, 22D-SML; SROM STM STD 36+12L 17X22; 11/13 S-ROM 40MM M SPEC+12; ALTRX +4 NEUT 40IDX66OD; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MULTIHOLE W/GRIPTION 66MM; S-ROM*SLEEVE PRX ZTT, 22D-SML; SROM STM STD 36+12L 17X22
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 137