MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC-2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136504000

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Weakness (2145); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: h6 (patient).Corrected: g1 (physical manufacturer).Udi (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 12/14 ARTICUL 40MM M SPEC-2
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10321473
• MDR Text Key: 200399867
• Report Number: 1818910-2020-16832
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,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 Expiration Date: 08/31/2023
• Device Catalogue Number: 136504000
• Device Lot Number: 8892323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 08/24/2020
• Supplement Dates FDA Received: 07/28/2020; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 40 MM WITH 2 MM NECK LENGTH; ALTRX NEUT 40IDX56OD; 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; PINN SECTOR W/GRIPTION 56MM; POLYETHYLENE 40 MM; SUMMIT POR TAPER SZ7 STD OFF; SUMMIT SIZE 7 PRESS FIT
• Patient Outcome(s): Required Intervention