MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PINN CAN BONE SCREW 6.5MMX25MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121725500

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/18/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address thigh pain.The stem was stable, but there was no bony in-growth.Update 7/18/12 - litigation papers received.It alleges that the patient suffers from pain, discomfort, mobility issues, implant loosening and wear.During the revision, the pinnacle liner remained intact, while the head was replaced with srom.Update ad 25 jun 2018: receipt of ppf and medical record.Ppf alleges abductor muscle repair, metallosis, elevated metal ions, loosening of the cup and stem.After review of medical record for mdr reportability, patient was revised to address "persisitent" pain and loosening of the femoral component.Added cup and screws due to alleged loosening.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # : (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8207875
• MDR Text Key: 131770665
• Report Number: 1818910-2019-79472
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121725500
• Device Lot Number: BP8BR4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR