MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. - 1818910 PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

Catalog Number 121725500

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Not Applicable (3189)

Event Date 12/18/2009

Event Type  Injury  

Event Description

Litigation papers allege that the patient suffered severe pain and discomfort.Update rec¿d (b)(4) 2012¿ pfs and medical records received.Part/lot was provided.After review of the medical records the patient was revised on (b)(6) 2009 for infection.On (b)(6) 2009, antibiotic spacers were removed, but it is unknown when they were placed so all products are now being reported from the primary operation.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(4) 2014.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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

(b)(4).

Event Description

In addition to what were previously reported, ppf alleges dislocation and infection.After review of medical records for the mdr reportability, patient was revised to address post infected hip.On (b)(6) 2008, patient underwent irrigation and debridement and obvious infection that was deep in the joint with 12 liters of pulsatile lavage were noted.There was no reported of dislocation at this time.Added revision hospital and expiration date.Updated manufacture date.Doi: (b)(6) 2008- dor: (b)(6) 2009 (right hip).

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 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. - 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 3806390
• MDR Text Key: 4477963
• Report Number: 1818910-2014-18624
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2012

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: 09/30/2017
• Device Catalogue Number: 121725500
• Device Lot Number: B4KC24000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 05/12/2014
• Supplement Dates Manufacturer Received: Not provided; 04/18/2018; 10/02/2018
• Supplement Dates FDA Received: 01/09/2015; 05/14/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2007
• 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: 54 YR
• Patient Weight: 84