MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-056

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

Patient Problems Pain (1994); Weakness (2145); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After review of the medical records, clinical visit reported pain, weakness, walking difficulty, decrease range of motion, sleeping difficulty and mild tightness.Doi: (b)(6) 2019, dor: not revised; 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.Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm absence of treatment, musculoskeletal stiffness, walking difficulty.

• Brand Name: ALTRX NEUT 40IDX56OD
• 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: 10332093
• MDR Text Key: 200600865
• Report Number: 1818910-2020-16959
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295393344
• UDI-Public: 10603295393344
• Combination Product (y/n): N
• PMA/PMN Number: K132959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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: 1221-40-056
• Device Catalogue Number: 122140056
• Device Lot Number: J5731C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC-2; 40 MM WITH 2 MM NECK LENGTH; BONE SCREWS 6.5 MM; BONE SCREWS 6.5 MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN SECTOR W/GRIPTION 56MM; POLYETHYLENE 40 MM; SUMMIT POR TAPER SZ7 STD OFF; SUMMIT SIZE 7 PRESS FIT; 40 MM WITH 2 MM NECK LENGTH; BONE SCREWS 6.5 MM; BONE SCREWS 6.5 MM; PINN SECTOR W/GRIPTION 56 MM; POLYETHYLENE 40 MM; SUMMIT SIZE 7 PRESS FIT
• Patient Outcome(s): Required Intervention