MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

Catalog Number 121725500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Skin Irritation (2076); Swelling (2091); Joint Disorder (2373); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Patient was revised for pain, clicking, and high metal ions.

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 at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd 12/13/2016 litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from swelling, inflammation, lack of mobility, infection, damage to the bone and surrounding tissue, and multiple dislocations.

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

Update apr 10, 2017 pfs and medical records received.Pfs alleges damage to surrounding bones and tissue, damage to other organs, and ambulation problems.After review of the medical records for mdr reportability, it was reported that patient experienced pain and mild osteolysis around the femoral implant and around the trochanteric region.It was also reported that the screw was not completely countersunk and the liner doesn't seat completely down into the base.At this time its unknown which screw wasn't seated correctly, we will leave both coded at ortho: no product failure indicated (if/when we receive more information we will update as needed).There were no indications of infection, dislocations, implant noise, or high metal ions.Laboratory values for cobalt and chromium were provided and it was below 7 ppb.This complaint was updated on apr 24, 2017.

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. .

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).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.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 will be filed as appropriate.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).

Event Description

Ppf alleges abductor muscle repair, metal wear and metallosis.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 5032302
• MDR Text Key: 24128533
• Report Number: 1818910-2015-29051
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Followup,Followup,Followup,Followup,Followup
• Report Date: 08/07/2015

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: 05/05/2019
• Device Catalogue Number: 121725500
• Device Lot Number: DS2DS4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/07/2018; 03/01/2019; 11/29/2019
• Supplement Dates FDA Received: 01/12/2017; 04/24/2017; 06/15/2018; 03/11/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 96