MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS 8/18.0 LRG ST; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number 1572-02-180

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

Patient Problems Ossification (1428); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).E3 initial reporter occupation: lawyer.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

(b)(6) 2021: patient has a consult regarding his right hip with persistent swelling that has occurred nearly a year after his revision.He has been aspirated several times with no signs of infection.Chromium and cobalt levels are normal.He has some numbness and pain radiating down the back of his leg.Mri shows a very large pseudotumor around the right hip that has recurred, as well as possible loosening of the right cup.X-ray review shows osteolysis around the stem proximally on the medial side.(b)(6) 2022: physical therapy note indicates, patient had a second pseudotumor removal from his hip on (b)(6) 2021.He has weakness and difficulty walking requiring physical therapy treatments.It is unknown if any implants were revised.(b)(6) 2022: patient cancels physical therapy visits, due to excessive ¿popping sounds¿ in his hip.Doi: (b)(6) 2020.Dor: unknown.Right hip second complaint.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing records evaluation (mre) was not performed, as no lot number was provided for this device.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring, for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing records evaluation (mre) was not performed, as no lot number was provided for this device.

Event Description

On (b)(6) 2022, x-ray findings right total hip prosthesis with acetabular cup and femoral stem indicated that there were no significant changes in irregularity and minimal heterotopic ossification involving the right greater trochanter.Surgical drain in place with small amount of pneumarthrosis and subcutaneous emphysema.No evidence of periprosthetic fracture.

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

• Brand Name: SOL SYS 8/18.0 LRG ST
• Type of Device: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16852330
• MDR Text Key: 314390410
• Report Number: 1818910-2023-09309
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295061465
• UDI-Public: 10603295061465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

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: 1572-02-180
• Device Catalogue Number: 157202180
• Device Lot Number: YG9ANA000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 07/12/2023
• Supplement Dates FDA Received: 06/06/2023; 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2004
• 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 10D 40IDX56O; DLT TS CER HD 12/14 40MM +8.5; PINNACLE 100 ACET CUP 56MM; SOL SYS 8/18.0 LRG ST
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male