MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ7 HI; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-13-135

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Synovitis (2094); Unspecified Tissue Injury (4559)

Event Date 09/20/2022

Event Type  Injury  

Event Description

Clinical notification received for revision due to aseptic loosening.Date of implant: (b)(6) 2017.Date of revision: (b)(6) 2022.(right hip).Treatment: revision; stem, head, and liner were revised.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for the device, it cannot be determined a depuy's device failure or malfunction which could contribute to the reported event.No misposition was able to be visualized.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.

Event Description

(b)(6) 2017: the patient underwent a primary right total hip arthroplasty utilizing depuy implants.(b)(6) 2022: surgeon states patient has a history of a fall, pain, and xrays that revealed loosening of the stem at the cement to bone interface with proximal remodeling of the proximal femur into varus and deformity of the midshaft of the femur.Intraoperative findings include cement-type debris and synovitis found within the joint.The stem was confirmed to be loose at the cement to bone interface.The following intraoperative fractures and surgical interventions also occurred during this (b)(6) 2022 revision.1.When attempting to remove the cement plug, an anterior perforation occurred by a long drill (manufacturer not mentioned) due to weak bone where the femur had previously remodeled into varus at the top of the stem (mispositioning and bone injury will be captured on the stem of this pc.Because manufacturer of the drill is unknown, a linked pc will not be created).2.A trochanteric osteotomy was then required to remove the cement plug as well as position the new stem.The trochanteric osteotomy was fixated with cerclage wires.Trochanteric osteotomies are an occasional necessity of revision surgeries and not considered an event to be captured within ecm.There are no allegations of product failure requiring the intervention.3.When trialing a size 22 stem, the femur fractured requiring cerclage wires to fixate.(this will be captured on a linked pc if the event is not found to be previously captured within the complaints system) 4.When the final size 21 stem was seated, the previously fixated trochanteric osteotomy extended into a fracture.(this will be captured on a linked pc if the event is not found to be previously captured within the complaints system).

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:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT CEMENTED STEM SZ7 HI
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15675273
• MDR Text Key: 302437886
• Report Number: 1818910-2022-21372
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295060260
• UDI-Public: 10603295060260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013352
• 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: 10/26/2022

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: 1570-13-135
• Device Catalogue Number: 157013135
• Device Lot Number: D17021008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 11/18/2022
• Supplement Dates FDA Received: 11/07/2022; 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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 +4 NEUT 36IDX52OD; ARTICULEZE M HEAD 36MM +1.5; CEMENTRALIZER 14.0; DEPUY CMW 1 40G; DEPUY CMW 1 40G; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 52MM; SUMMIT CEMENTED STEM SZ7 HI
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White