MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
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.Occupation: lawyer.(b)(4).
Event or Problem Description
The patient was revised to address pain.Surgeon chose to remove mom liner and replace with polyethylene liner and new head.Revision notes indicated that the stem was found to be in good condition without evidence of metallic corrosion.Surgeon was going to try to utilize a ceramic +9 head on a poly, but after inspecting the head, there were a couple of surface abrasion.Due to the irregularities of having issues with premature wear, the ceramic head was removed and replaced with a cobalt chrome head.Doi: (b)(6) 2007, dor: (b)(6) 2018, 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.

• Brand Name: SUMMIT POR TAPER SZ2 STD OFF
• Common Device Name: SUMMIT 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10453826
• Report Number: 1818910-2020-18772
• Device Sequence Number: 4092534
• Product Code: MRA
• UDI-Device Identifier: 10603295059332
• UDI-Public: 10603295059332
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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 Expiration Date: 08/31/2016
• Device Model Number: 1570-01-080
• Device Catalogue Number: 157001080
• Device Lot Number: A22CB1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2006
• 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: ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; UNKNOWN HIP FEMORAL HEAD; ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 70 KG