MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SUMMIT

Catalog Number UNK HIP FEMORAL STEM SUMMIT

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2021

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 as " my mother (b)(6) is having her hip replaced (b)(6) 2021.Because she has issues with her depuy johnson & johnson hip put in (b)(6) 2008.I am her daughter (b)(6) and have poa.She is suffering from issues due to the hip.High cobalt and chromium levels in her blood stream which may have led to her memory issues, heart issue along with corrosion of bone and tissue muscle her doctor can explain better than i can, (b)(6) orthopedic surgeon at (b)(6).Nurse (b)(6).I have provided the original information of when she originally had hip replace in 2008, (b)(6).Long operative note - (b)(6).(m.D.) - (b)(6) 2008 12:00 am pdt.Preoperative diagnosis: severe right hip pain.Postoperative diagnosis: severe right hip pain due to complete collapse of the right femoral head.Surgical procedure: right total hip arthroplasty using the depuy total hip system.Stem was summit size 4 high offset.Cup was 50 asr cup.Head was 45 mm femoral head, cobalt chrome.Neck was minus-1 neck.(b)(6).(mrn: xxxxxxx) ¿ printed at (b)(6) 2021 10:38 am page 6 of 8.I would like to know what your company can do to compensate her for all we have been through, please respond as soon as possible.".

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.E3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of the medical records, the patient was revised to address osteolysis and pseudotumor right hip.Also reported mental confusion alleged due to hip issue.Operative note reported thickened and bulging capsule.Thick yellow amorphous pseudotumor, osteolysis around the acetabulum.There were visible columns of hard sclerotic bone into the cup traversing the osteolysis.Pseudotumor inside metal head, metallosis at the head/ neck junction and trunionosis.Lab result shows elevated metal ions.Doi: (b)(6) 2008, dor: (b)(6) 2021, right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12746853
• MDR Text Key: 284817876
• Report Number: 1818910-2021-24333
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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 Catalogue Number: UNK HIP FEMORAL STEM SUMMIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 11/04/2021; 11/05/2021
• Supplement Dates FDA Received: 11/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CUP WAS 50 ASR CUP; HEAD WAS 45 MM FEMORAL HEAD COBALT CHROME; NECK WAS MINUS-1 NECK; STEM WAS SUMMIT SIZE 4 HIGH OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female