MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT

Catalog Number 121730500

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Host-Tissue Reaction (1297); No Information (3190)

Event Date 11/21/2011

Event Type  Injury  

Event Description

Pfs and medical records received.It should be noted these records were received through a pfs.Formal litigation hasn¿t been filed yet, so this complaint isn't legal.Pfs alleges pain, itching, and hives for 2 years.Part/lot information provided.After review of the medical records the patient was revised for pain and the head and liner were revised.The screw in the cup was also prominent so it is also being reported for migration.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The devices associated with this report were not returned.Per wi-3430, a review of the device history records is no longer required for the metal head and metal liner provided product and lot combinations.A complaint database search finds no other reported incidents against the remaining product and lot combination.Medical records were provided and reviewed by a medical professional.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.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

Ppf alleges abductor muscle repair.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.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 6.5MMX30MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 3878624
• MDR Text Key: 15997481
• Report Number: 1818910-2014-21283
• 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
• Report Date: 12/19/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 121730500
• Device Lot Number: 417248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2009
• 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: 67 YR
• Patient Weight: 79