MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY 36+1.5 METAL FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-HIP

Device Problems Naturally Worn (2988); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/16/2015

Event Type  Injury  

Event Description

Patient was revised to address pain.

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.Udi unavailable.Followup with the complainant has been conducted for the catalog number and lot number, and the information is not available.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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

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

Event Description

Update oct 27, 2017: pfs record received.In addition to what was previously alleged, pfs alleges clicking and popping, difficulty in mobility, sciatic nerve pain, inability to sleep, and swelling.It was also reported that the patient had a broken femur from the revision.Added complainant information.This complaint was updated on nov 2, 2017.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.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.

Event Description

Update oct 27, 2017: pfs record received.In addition to what was previously alleged, pfs alleges clicking and popping, difficulty in mobility, sciatic nerve pain, inability to sleep, and swelling.It was also reported that the patient had a broken femur from the revision.Added complainant information.This complaint was updated on nov 2, 2017.

Event Description

Ppf alleges bone fracture, loosening of stem, metal wear, metallosis, and elevated metal ions.Pfs alleges pain, walking difficulty, and elevated metal ions.

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.Udi: (b)(4).

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).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: UNKNOWN DEPUY 36+1.5 METAL FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4628204
• MDR Text Key: 5762072
• Report Number: 1818910-2015-17033
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/16/2015

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 Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided; 10/27/2017; 10/27/2017; 11/16/2017; 03/14/2019; 01/22/2020
• Supplement Dates FDA Received: 04/08/2015; 11/03/2017; 11/08/2017; 11/28/2017; 04/03/2019; 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 123