MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SROM STM STD 36+12L 15X20; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Impaired Healing (2378)
Date of Event	05/11/2021
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
Clinical adverse event received for hematoma and failure of wound to heal event is serious and is considered severe there is a remote possibility that the event is related to device and is probably related to procedure.Procedure notes (b)(6) 2021 indicate the patient received a left total hip irrigation and debridement with placement of wound vac due to continued drainage of the wound.
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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Question: 1.Follow-up for which apex hole eliminator(product details) a.''you have provided us two differing apex hole eliminators.As it is not possible for the patient to have had two of them implanted, which one was in place at the time of this revision? answer: the original apex hole elimator was probably damaged or stripped so a new one was required on (b)(6) 2013.
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.

• Brand Name: SROM STM STD 36+12L 15X20
• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12062886
• Report Number: 1818910-2021-13533
• Device Sequence Number: 3959446
• Product Code: JDI
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 06/10/2021

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: 56-3620
• Device Catalogue Number: 563620
• Device Lot Number: 3492773
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 08/10/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/04/2021; 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN LNR CON +4 NEUT 40IDX64OD; PINNACLE SECTOR II CUP 64MM; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM STM STD 36+12L 15X20; APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN LNR CON +4 NEUT 40IDX64OD; PINNACLE SECTOR II CUP 64MM; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM STM STD 36+12L 15X20
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 88