MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ6 HI; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-13-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to infection date of implantation: (b)(6) 2013.Date of revision #1: (b)(6) 2013.Date of revision #2:(b)(6) 2015.Date of revision #3: (b)(6) 2021.Date of revision #4: (b)(6) 2021.Date of revision#5: (b)(6) 2022.(left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).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).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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Patient underwent removal of temporary antibiotic-loaded spacer with placement of final implants secondary to chronic infection of the left hip.¿devitalized¿ tissue was found due to the previously large fluid collections he experienced.There was also a small 2cm central defect in the acetabulum.The surgeon decided to remove the bipolar construct and replace with another bipolar due to the patient¿s history of recurrent dislocations.The final reclaim stem and bipolar head were placed successfully.The devitalized tissue and central defect were noted to be due to the recurring infection process that has now been cleared.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 clinical code: unspecified tissue injury (e2015) is used to capture bone injury and soft tissue injury.

• Brand Name: SUMMIT CEMENTED STEM SZ6 HI
• 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): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15520643
• Report Number: 1818910-2022-19240
• Device Sequence Number: 14977435
• Product Code: JDI
• UDI-Device Identifier: 10603295060253
• UDI-Public: 10603295060253
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2022

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: 1570-13-120
• Device Catalogue Number: 157013120
• Device Lot Number: D21103229
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/09/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/02/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2021
• 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: ARTICUL/EZE BALL 28 +12 BLK; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; SELF CENT HIP 65X28 GRN; SUMMIT CEMENTED STEM SZ6 HI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 88 KG