MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 28MM +0; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Model Number	1365-28-210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/04/2022
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
Patient underwent primary thr where a competitor femoral component and a competitor acetabular component was utilised (dr.(b)(6), date unknown).Patient presented with pain and the components were removed and a temporary "kiwi" spacer implanted - competitor stem and cup (dr.(b)(6), date unknown) patient was returned for the second of the two stage procedure where a competitor acetabular shell with dual mobility and an srom stem was utilised ((b)(6) 2022).Patient has presented with ongoing pain and a decision was made to perform a washout with liner exchange and a head exchange ((b)(6) 2022).No obvious signs of infection were evident.Unsure whether any organisms have been cultured.Did the patient experience a post-op device malfunction? unknown, if yes, please describe.Possible infection - but this suspected at time of s rom stem implantation as this was the second of a two stage procedure, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? yes, facility name of original implant: (b)(6) hospital, was device explanted? true, hardware/explant removal due to: washout and head/ liner exchange, did patient require revision surgery? true, if yes, date of revision surgery.(b)(6) 2022, reason for revision surgery.Infection suspected - washout, patient status/ outcome/ consequences, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? possible/ suspected infection, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown, (b)(6).Device property of? none, device in possession of? none, (b)(6).Device property of? none, device in possession of? none, (b)(6).Device property of? none, device in possession of? none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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.Corrected: e4.
Event or Problem Description
Additional information received.The affected side of the patient is the 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.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.

• Brand Name: DELTA CER HEAD 11/13 28MM +0
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15067068
• Report Number: 1818910-2022-13575
• Device Sequence Number: 14881004
• Product Code: LZO
• UDI-Device Identifier: 10603295033240
• UDI-Public: 10603295033240
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2022

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: 1365-28-210
• Device Catalogue Number: 136528210
• Device Lot Number: 9371238
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 11/17/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/23/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: S-ROM*SLEEVE PRX ZTT, 18F-XXL; SROM*STM LG 36+8L 18X13X215N; STRYKER ACETABULAR LINER; STRYKER ACETABULAR SHELL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown