MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOLUTION A 8IN BOW 16.5 RT; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number 917186000

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

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Patient underwent tha in 1991 with stryker implants.Revision was completed using depuy products in 2010.After the revision surgery, dislocation had occurred in 2016 and (b)(6) 2021.A second revision was completed due to chronic expanding hematoma around the hip joint.Since trunnionosis was suspected, the surgeon decided not to remove the stem and cut the femur distal to the stem.Next, the surgeon inserted implants for tumor.

Manufacturer Narrative

Product complaint # (b)(4).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 associated with this report was received for examination.There is not evidence that the allegation is product related.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: SOLUTION A 8IN BOW 16.5 RT
• Type of Device: SOLUTION STEM IMPLANTS : 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: 14851033
• MDR Text Key: 294906494
• Report Number: 1818910-2022-11953
• 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: 06/29/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 917186000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/13/2022
• 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 28MM +3; STRYKER BONE CEMENT; UNK HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR LINERS; ZIMMER BIOMET
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 58 KG