MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; BONE SCREWS AND PINS : SCREWS

Model Number 1217-25-500

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

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the patient presents with groin pain.Surgeon believes cup could be loose.Head is removed, followed by liner, screw and hole eliminator.Cup insertion handle is attached to shell and found to be well fixed and appropriate orientation.Range of motion did show some impingement with internal rotation.Trial reduction was most stable with a +4/10 degree liner and one longer ball.Scar tissue was removed from where the impingement was taking place.Doi: (b)(6) 2017; dor: (b)(6) 2020; right hip.

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:  corrected: d11.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10300028
• MDR Text Key: 199871134
• Report Number: 1818910-2020-16314
• Device Sequence Number: 1
• Product Code: NDJ
• UDI-Device Identifier: 10603295009900
• UDI-Public: 10603295009900
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1217-25-500
• Device Catalogue Number: 121725500
• Device Lot Number: D17040473
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX54OD; ALTRX +4 NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; DLT TS CER HD 12/14 36MM +1.5; DLT TS CER HD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 54MM; TRI-LOCK BPS SZ 4 HI OFFSET; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86