MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-110

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

Patient Problems Fall (1848); Fatigue (1849); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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 head and liner exchanged was performed.Metal liner was replace with polyethylene liner.Metal head was removed and ceramic ts head was implanted.Pc has been re-opened due to receipt of medical records.After review of medical records, visit notes reported that patient has had fall resulting to cognitive changes after, pain, fatigue, dizziness, wobbling and weakness.Lab results show metal ions above 7 ppb.Doi: unknown.Dor: (b)(6) 2020.Affected side: unknown.

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ5 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: 10550235
• MDR Text Key: 207503917
• Report Number: 1818910-2020-20433
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059363
• UDI-Public: 10603295059363
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1570-01-110
• Device Catalogue Number: 157001110
• Device Lot Number: CP6E91000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +5; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR