MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX40MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121740500

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 09/11/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Ad 31 jan & 23 feb 2018: medical records received.After review of medical records for the mdr reportability, patient was revised to address loosening of the hip prosthesis cupula with bone loss.Clinical notes reported of limping, and bony callus.Head will be reported since it was revised.There is no products or sticker sheets provided in the source document implanted on (b)(6) 2013.Doi: (b)(6) 2013 ; dor: (b)(6) 2014 (left hip).(b)(4) for first revision; (b)(4) for third revision.

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX40MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7442840
• MDR Text Key: 105901244
• Report Number: 1818910-2018-57796
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010395
• UDI-Public: 10603295010395
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 121740500
• Device Lot Number: D12081049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2018
• Date Device Manufactured: 11/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR