MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SUMMIT

Catalog Number UNK HIP FEMORAL STEM SUMMIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled "outcomes of conversion tha after failed porous tantalum implant for osteonecrosis of the femoral head: a comparative matched study" written by jinhi ma, bailiang wang, debo yue, wei sun, weiguo wang, and zirong li published by hip international published online/accepted by publisher april 12, 2019 was reviewed.The article¿s purpose was to compare clinicoradiologic outcomes and complications of tha after failed porous tantalum implantation (pti) with those of primary tha without any previous surgery for osteonecrosis of the femoral head (onfh).Pti group had 34 hips (32 patients) underwent a tha after a failed pti (competitor product) and primary group had 32 hips (25 patients) underwent tha after no previous operations.All patients were implanted with pinnacle cup, corail or summit stem, and a ceramic on ceramic or ceramic on poly bearing.Findings: no significant complications after tha between the 2 groups.No dislocation, intra-operative fracture, infection, osteolysis, dvt, sciatic nerve palsy, or squeaking were observed in either group.No hip required revision surgery during the follow-up period.Leg length discrepancy was noted in both groups.No mention of how many hips involved and no treatment indicated.Depuy products: corail femoral stem.Summit femoral stem.Pinnacle acetabular cup.Ceramic femoral head.Ceramic or polyethylene acetabular liner.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary:no device associated with this report was received for examination.Images within the journal article have been reviewed.Most images do not depict depuy devices.The x-ray images depicting the implanted devices manufactured by depuy does not find anything indicative of a product problem.The information received will be retained for potential series investigations if triggered by trend analysis 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: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11170957
• MDR Text Key: 231336048
• Report Number: 1818910-2021-01091
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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 FEMORAL STEM SUMMIT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention