MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM 28MM +6 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-18-500

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

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 Description

Patient in pain, pseudo tumor, revision of right hip.Metal on metal device.Patient required revision surgery or hardware removal.

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 alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.Per wi-3430, it has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.

• Brand Name: SROM 28MM +6 M HEAD
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11880266
• MDR Text Key: 261230558
• Report Number: 1818910-2021-11156
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295033165
• UDI-Public: 10603295033165
• Combination Product (y/n): N
• PMA/PMN Number: K893872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-18-500
• Device Catalogue Number: 136518500
• Device Lot Number: YED-05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT28IDX50OD; S-ROM*SLEEVE PRX ZTT, 14B-SML; S-ROM*STM STD,36NK,14X09X130
• Patient Outcome(s): Required Intervention