MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROTRUSIO CAGE 48ODX45ID R; MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES

Model Number 1011-85-000

Device Problems Fracture (1260); Migration (4003)

Patient Problems Pain (1994); Discomfort (2330); Joint Laxity (4526); Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Subject id: (b)(6).Study: (b)(6).Clinical adverse event received for slight shifting of the cage into the pelvis : abnormal radiographic evaluation.Event is serious and is considered moderate.Event is definitely related to device and is definitely not related to procedure.Date of primary implantation: (b)(6) 2019.Date of revision: (b)(6) 2019.Date of event (onset): (b)(6) 2021.(right hip).Treatment: a ct scan will be obtained to rule out proximity of implants to major pelvic blood vessels.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of the provided x-ray images find sufficient evidence to confirm the reported observation.There is unknown secondary acetabular bone repair product implanted in addition to the depuy protrusio cage and bone screws.Use of these depuy devices is indicative of pre-existing problems associated with patient acetabular bone condition.Product error is not identified.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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

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

Event Description

Clinical records, from clinical visits on (b)(6) 2021 and on (b)(6) 2021, reported that the patient had a failed total hip with a protrusio cage pelvic construct, with the cage having fractured partially and migrated into the pelvic cavity.X-rays demonstrated this.The patient was experiencing only minor pain and discomfort, and some sciatica, despite this, and was ambulatory and capable of modified activities of daily living using appliances.The surgeon indicated that the progression of the cage's failure might have reached an endpoint, as the patient's trochanter was now impinging on the pelvic wing, preventing the femoral head from encroaching into the pelvis any further.As a consequence, the patient's leg was shortened.A ct scan had been ordered to be certain that the cage was not threatening any major pelvic blood vessels.The plan at present is to hold off on doing any surgical intervention, as this is considered a very high risk surgery due to the approach requiring involvement with intrapelvic tissues, vessels, and organs.

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

Event Description

Pe code update to report implant fracture of the protrusio cage.

• Brand Name: PROTRUSIO CAGE 48ODX45ID R
• Type of Device: MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12583358
• MDR Text Key: 274951470
• Report Number: 1818910-2021-22108
• Device Sequence Number: 1
• Product Code: JDJ
• UDI-Device Identifier: 10603295000655
• UDI-Public: 10603295000655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962007
• 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,Followup,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-85-000
• Device Catalogue Number: 101185000
• Device Lot Number: 348034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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 32IDX48OD; ARTICUL/EZE BALL 32 +1 GR; CEMENTRALIZER 13.0; DEPUY CMW 1 40G; DEPUY CMW 2 20G; DEPUY/CMW 2G; DEPUY/CMW 2G; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PROTRUSIO CAGE 48ODX45ID R; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW20MM; SLF TAPPING ROOF PILE SCRW25MM; SLF TAPPING ROOF PILE SCRW25MM; SLF TAPPING ROOF PILE SCRW30MM; SLF TAPPING ROOF PILE SCRW30MM; SUMMIT CEMENTED STEM SZ6 HI; ALTRX NEUT 32IDX48OD; ARTICUL/EZE BALL 32 +1 GR; CEMENTRALIZER 13.0; DEPUY CMW 1 40G; DEPUY CMW 2 20G; DEPUY/CMW 2G; DEPUY/CMW 2G; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PROTRUSIO CAGE 48ODX45ID R; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW20MM; SLF TAPPING ROOF PILE SCRW25MM; SLF TAPPING ROOF PILE SCRW25MM; SLF TAPPING ROOF PILE SCRW30MM; SLF TAPPING ROOF PILE SCRW30MM; SUMMIT CEMENTED STEM SZ6 HI
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White