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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); No Code Available (3191)

Event Date 05/05/2020

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

Clinical adverse event received for pulmonary embolism diagnosed the end of (b)(6).Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020.(left hip).

Event Description

Revision operative notes provide information that the primary left tha included an asr cup and head, a ztt femoral sleeve, and an unk depuy femoral stem.Date of implantation and part/lot information were not provided.These products have not been previously reported.Records indicate the primary tha procedure occurred 10 years earlier by a dr.Edwards in laramie, wyoming.Dor: (b)(6) 2020: patient received a complete left thr to treat pain and discomfort secondary to armd and massive acetabular and femoral osteolysis.Upon entering the joint, the surgeon identified and excised stained periarticular synovial tissue and fluid consistent with metallosis and foreign body reaction.The pseudocapsule was debrided.There was some deficiency of the gluteus medius, which was repaired.The asr cup was malpositioned and had significant eccentric wear which produced the metallosis.Upon removal of the asr cup, the surgeon identified significant retroacetabular osteolysis which was removed and reconstructed with fresh frozen allograft.The osteolytic lesions in the ischium, pubis, and superior regions of the acetabulum, which required the revision cup to be secured with screws.The ztt femoral sleeve was well in grown but there were osteolytic lesions into the trochanter and around the iliopsoas tendon.The stem was well-fixed but revised due to the femoral osteolysis.Allograft was used to repair the lesions on the femur.The manufacturer of the stem was not identified but assumed to be a depuy product due to the use of the ztt sleeve.The patient received a depuy tha at revision.The procedure was completed without complications.(activity to capture this event was added to the update on (b)(4)) phone call dated (b)(6) 2020: patient called to inform the surgeon about being diagnosed with a pulmonary embolism at the end of april and more recently, with e dvt of an unspecified lower extremity.The patient developed the pe and dvt while on eloquis.The patient reports that the tha is performing nicely.No treatment was identified.The conditions under which the patient developed the pe and dvt were not provided.(captured on (b)(4)) clinic visit dated (b)(6) 2020: patient is four months status post left tha.Physical exam identifies a mild limp due to a 1.09 cm leg length discrepancy.Patient reports some mild soreness that dissipates with walking and no interruption in mobility or adls.X-rays identify a well-fixed, stable tha.No interventions are required, and patient is free to resume full activity as tolerated.(captured on (b)(4)) dor: (b)(6) 2020; doe:(b)(6) 2020 (pe and dvt reported); doe: (b)(6) 2020 (limb asymmetry); left hip.

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: added: b5, h6 (patient); h6 patient code: no code available (3191) was used to capture limb asymmetry.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).Investigation summary :no device associated with this report was received for examination.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.

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:  corrected h6 (2100) patient code to capture thrombosis that was previously reported is now being removed since it relates to a different event if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10079893
• MDR Text Key: 191731979
• Report Number: 1818910-2020-12432
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN REVISION W/GRIPTION 60MM.; UNKNOWN HIP FEMORAL AUGMENT.; UNKNOWN HIP FEMORAL STEM.; PINN REVISION W/GRIPTION 60MM; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 86