MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 14/16 LG TAPER M HEAD 36MM+0; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1018-36-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient had a large hematoma that caused hip pain.The doctor irrigated the hematoma and removed ho.Head was replaced.Original implant date unknown.Doi: unknown, dor: (b)(6) 2021, affected side: left hip.
Additional 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 : it is not suspected that this device was the direct cause of the hematoma reported.Per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.A manufacturing records evaluation (mre) was not performed.

• Brand Name: 14/16 LG TAPER M HEAD 36MM+0
• Common Device Name: LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11435756
• Report Number: 1818910-2021-04568
• Device Sequence Number: 16965923
• Product Code: LPH
• UDI-Device Identifier: 10603295001362
• UDI-Public: 10603295001362
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 1018-36-500
• Device Catalogue Number: 101836500
• Device Lot Number: 3622325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention