MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS STEM CLRD HO 5; HIP IMPLANT FEMORAL STEM

Model Number 4742-05-200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Fall (1848); Inadequate Osseointegration (2646); Limb Fracture (4518)

Event Date 08/03/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical notification received for revision due to periprosthetic fracture.Date of implant: (b)(6) 2022.Date of revision: (b)(6) 2022.(right hip).Treatment: revision; stem, head, and liner were removed.

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.H10 additional narrative: added: b1 (product problem), b5, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 medical device problem code.

Event Description

On (b)(6) 2022, the patient had a right total hip arthroplasty to address primary osteoarthritis, end-stage.Depuy components were implanted during this procedure.On (b)(6) 2022, the patient had a revision of all components to address the right hip periprosthetic femur fracture with gross loosening of the femoral.Orif periprosthetic femur fracture using 3 synthes braided cables and 5 synthes cerclage wires, including orif of the greater trochanter.Depuy components were implanted during this procedure.The indications for surgery included a fall, and radiographs showed subsidence of the stem, femoral bone fracture, femoral stem loosening.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available x-rays were reviewed and found insufficient information to confirm implant loosening.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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: EMSYS STEM CLRD HO 5
• Type of Device: HIP IMPLANT FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15427192
• MDR Text Key: 299945573
• Report Number: 1818910-2022-17932
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295505358
• UDI-Public: 10603295505358
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4742-05-200
• Device Catalogue Number: 474205200
• Device Lot Number: 3763244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX52OD; ARTICULEZE M HEAD 36MM +5; EMSYS STEM CLRD HO 5; PINNACLE SECTOR II CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White