MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Litigation received.Litigation alleges elevated metal ions, instability, pain, swelling, inflammation, damage to surrounding bone and tissue and problems with walking.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what were previously alleged, ppf alleges metal wear, metallosis and implant fracture.After review of medical records, clinical visit notes reported that patient had osteolysis and erosion in the acetabular and femoral component which is consistent with synovitis, however no operative notes were provided to verify the reported erosion.Unknown hip implant has been added to captured the allegation of a fracture as its unknown where the fracture was.If/when more information is received, the pc will be updated as needed.

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.   added: (patient and device code).Corrected: patient identifier.

Manufacturer Narrative

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.

Event Description

After review of medical records, clinic visit notes reported of low back pain radiating to right hip, no popping, patient wasn't able to stand up and hasn't been able to walk.Patient was revised to address failed right hip arthroplasty.Revision notes reported that they encountered a very tenacious, fibrous reactive tissue on the joint, consistent with necrosis.A 2x3 cm lateral troch cyst on the lesser trochanter and a 7 cm lesion on the proximal femur was noted.Patient was bilateral, however, the devices implanted on the left hip were non-depuy.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A singular x-ray image has been provided and reviewed.No device fracture, disassociation or anything indicative of a product problem is identified.A root cause for the problems reported could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis 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 : a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN DEPUY STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 7046384
• MDR Text Key: 92585141
• Report Number: 1818910-2017-29442
• Device Sequence Number: 1
• Product Code: KWY
• 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: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 79 KG