MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-100

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Test Result (2695); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/21/2020

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 the patient presented with high metal count in blood.Removed metal on metal cup system and head and replaced.Doi: (b)(6) 2010; dor: (b)(6) 2020; left hip.

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, a follow-up medwatch will be filed as appropriate.

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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone injury (e20).

Event Description

After review of the medical records the patient was revised to address metallosis.Operative note reported scar tissues, scant amount of clear yellow fluid and minimal bone loss.

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 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.H10 additional narrative: added: b5, d10, g2, h6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e1, e2, e3.E3 initial reporter occupation: lawyer.

Event Description

Litigation records alleges pain, bone and tissue destruction, injuries and emotional distress.Doi: (b)(6) 2010 dor: (b)(6) 2020 left hip.

• Brand Name: SUMMIT POR TAPER SZ4 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: 9665269
• MDR Text Key: 177629771
• Report Number: 1818910-2020-03875
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295059356
• UDI-Public: 10603295059356
• 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,Followup,Followup
• Report Date: 01/21/2020

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 Expiration Date: 07/31/2020
• Device Model Number: 1570-01-100
• Device Catalogue Number: 157001100
• Device Lot Number: E2FEH1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/12/2020; 04/14/2021; 06/18/2021
• Supplement Dates FDA Received: 03/16/2020; 04/23/2021; 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE MTL INS NEUT36IDX52OD.; PINNACLE SECTOR II CUP 52MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR