MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Adhesion(s) (1695); Purulent Discharge (1812); Fatigue (1849); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Scar Tissue (2060); Vomiting (2144); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	08/29/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
New etq record created in order to update etq (legacy system) complaint number(b)(4).Reason for original complaint.-litigation alleges patient experienced severe pain and discomfort, difficulty walking, sitting, and standing, and swelling.Doi: (b)(6) 2009 - dor: none reported.(left hip).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Updated event description: on (b)(6) 2020, patient was scheduled to have left hip replacement.Was given versed and developed complications.So the surgery was postponed.Patient had stool incontinence and vomiting.Ct showed colitis and nephrolithiasis.On (b)(6) 2020, follow-up for hip replacement.Patient reports having pain.Patient was having a follow-up for type 2 diabetes.And it was mentioned, that he underwent a left hip replacement in lovonia.And procedure went well, but the patient has had some post operative complication.The patient has a draining lesion at the superior aspect of the roughly 15 cm scar and is taking bactrim daily.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ4 HI 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17451093
• Report Number: 1818910-2023-15914
• Device Sequence Number: 15269051
• Product Code: LPH
• UDI-Device Identifier: 10603295060055
• UDI-Public: 10603295060055
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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 Catalogue Number: 157011100
• Device Lot Number: DE5CC1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 09/06/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/09/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2009
• 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; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 93 KG