MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 9/10 COCR HEAD 28MM +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-059
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 june 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.
Additional 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.
Additional 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: 9/10 COCR HEAD 28MM +3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• 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: 14851049
• Report Number: 1818910-2022-11952
• Device Sequence Number: 2351366
• Product Code: JDI
• UDI-Device Identifier: 10603295276647
• UDI-Public: 10603295276647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1521-90-059
• Device Catalogue Number: 152190059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOLUTION A 8IN BOW 16.5 RT; STRYKER BONE CEMENT; UNK HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR LINERS; ZIMMER BIOMET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 58 KG