MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US J ENDURANCE SZ 1; MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

Catalog Number 152190001

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> (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.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 that on (b)(6) 2008, the patient underwent the bipolar hip arthroplasty with the stem, the cup, and the head for the hip joint.The surgery was completed successfully without any surgical delay.After the surgery, the patient complained of pain in the hip joint this year.The x-rays showed that the implants were loosened.Therefore, the surgeon removed the implants, and the total hip arthroplasty was performed with the stryker¿s implants.The revision surgery was completed successfully without any surgical delay.According to the surgeon, the cause of loosening seemed to be cement degradation over time.No further information is available.

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, post market surveillance, 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed corrected: h5.

• Brand Name: J ENDURANCE SZ 1
• Type of Device: MISCELLANEOUS HIP STEM : 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: 14840893
• MDR Text Key: 295064958
• Report Number: 1818910-2022-11866
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 152190001
• Device Lot Number: BS9EM1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/05/2022
• 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: 9/10 COCR HEAD 22.225MM -3; J ENDURANCE SZ 1; J-FX BIPOL SHEL&22.225LNR/43MM
• Patient Outcome(s): Required Intervention