MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL

Catalog Number UNK FEMORAL TRIAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 08/06/2021

Event Type  Injury  

Event Description

Litigation record received.Patient experienced painful lump/bulge and discomfort in groin and down right thigh, and inability to fully perform physical therapy, inability to ambulate properly and without pain, frustration and depression, unnecessary scarring, permanent instability after the trial femoral ball had been left inside the patient's groin.Doe: (b)(6) 2021.

Manufacturer Narrative

(b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.A-8608295 - jan 27 2023: on (b)(6) 2021, patient underwent a total right hip replacement at taylor hospital wherein the surgical team failed to realize that the trial femoral ball had been left in patient's groin.During the clinical visits on (b)(6), (b)(6), and (b)(6) 2021, patient continued to complain of pain in the groin and right thigh together with lump in groin area but surgeon stated that these were expected after surgery and were normal.Until (b)(6) 2021, patient had a urology well visit and ordered a ct scan and revealed a rounded radio dense structure in the area of patient's groin.On (b)(6) 2021, patient was sent for an xray due to pain.On (b)(6) 2021, during clinical visit, the surgeon stated that the ct scan revealed the trial femoral ball inside the groin area.The patient was scheduled for removal of the trial ball and on (b)(6) 2021, patient underwent a removal of trial femoral ball.The device catalog number is unknown; therefore, udi is unavailable.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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device was received for examination, therefore the reported event could not be confirmed.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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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

Medical records received.On (b)(6) 2021, the patient had a right total hip replacement to address right hip degenerative joint disease.Page 35 of 496 sticker sheet for (b)(6) 2021 included pinnacle acetabular cup, apex hole eliminator, biolox delta ceramic femoral, head, altrx poly liner, corail stem on (b)(6) 2021 the patient had a removal of a foreign body (trial head), right hip prior to surgery, the patient reported feeling a lump in her groin.A ct scan was reported to show a trial head in the patient's soft tissue.The surgeon was able to remove the femoral head trial.

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: 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.

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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: mri impression during the clinic visit of the patient.The right femoral shaft component of the prosthesis in the adjacent bone concerning for mediastinal air loosening.

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

Medical records received.On (b)(6) 2022 an nm2 bone scan was ordered due to mechanical loosening of internal right hip prosthetic joint.The scan shows subtle increased radiotracer activity tip in the right femoral shaft component of the prosthesis.

Event Description

Medical records ad (b)(6) 2024 this pertains to non mom construct was reviewed by clinician.(b)(6) 2021, trial implant used for sizing inadvertently was not removed prior to wound closure.Right total hip arthroplasty to address pain, pain over incision, edema depuy components were implanted during this procedure.(b)(6) 2021, ultra sound is reported to show a there is a fairly smooth rounded structure causing dense shadowing.(b)(6) 2021, the patient had a right hip removal of foreign body, trial femoral head implant.(page 652 of 3767) removed successfully without any complications.Preoperative ct scan revealed a trial head was located in the subcutaneous tissues.Prior to surgery, the patient was reported to have experienced pain and swelling.

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.

• Brand Name: UNK FEMORAL TRIAL
• Type of Device: FEMORAL TRIAL
• 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: 16276644
• MDR Text Key: 308530215
• Report Number: 1818910-2023-02556
• Device Sequence Number: 1
• Product Code: HWT
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FEMORAL TRIAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• 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: ALTRX +4 NEUT 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; CORAIL2 LAT COXA VARA SIZE 13; PINNACLE 100 ACET CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White