MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK HIP FEMORAL STEM

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Irritation (1941); Pain (1994); Tissue Damage (2104)

Event Date 09/22/2017

Event Type  Injury  

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

Sep 22, 2017: pfs and medical records received.After review of the medical records for the mdr reportability, it was stated that after patient's 1st revision ((b)(6) 2008), patient had experienced pain and trochanteric bursitis.There is no 2nd revision reported at this time.Update sep 22, 2017 reviewed records for reportability.Identified that during revision surgery (b)(6) 2008, surgeon explanted s-rom stem (leaving the s-rom sleeve) and replaced it with another stem.There is no record of this new stem on the implant record for (b)(6) 2008, but it is clearly noted in the or revision operative note.Added an unknown s-rom stem for alleged pain.

Manufacturer Narrative

:  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.

Event Description

Complaint description: sep 22, 2017: pfs and medical records received.After review of the medical records for the mdr reportability, it was stated that after patient's 1st revision (b)(6) 2008), patient had experienced pain and trochanteric bursitis.There is no 2nd revision reported at this time.Update sep 22, 2017 reviewed records for reportability.Identified that during revision surgery (b)(6) 2008, surgeon explanted s-rom stem (leaving the s-rom sleeve) and replaced it with another stem.There is no record of this new stem on the implant record for (b)(6) 2008, but it is clearly noted in the or revision operative note.Added an unknown s-rom stem for alleged pain.Complaint updated on: oct 20, 2017 / | investigation method: / | investigation summary:.

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.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6965895
• MDR Text Key: 89859358
• Report Number: 1818910-2017-27153
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 57