MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-120

Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494); Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that stem/head were revised for periprosthetic fracture.It was also reported that there was loosening of the stem at cement to implant interface.Doi: (b)(6) 2020.Dor: (b)(6) 2020; affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: b5, h6 patient code.Corrected:  h6 device code (previous code off-label use will be retracted).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that there was no cement used during the primary surgery.

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.

• Brand Name: SUMMIT POR TAPER SZ6 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10755185
• MDR Text Key: 213661705
• Report Number: 1818910-2020-23539
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059370
• UDI-Public: 10603295059370
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-01-120
• Device Catalogue Number: 157001120
• Device Lot Number: 9481717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 11/25/2020
• Supplement Dates FDA Received: 11/11/2020; 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +5; ARTICULEZE M HEAD 36MM +5
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR