MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C-STEM AMT SZ1 HI OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	1570-14-070
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	12/20/2021
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
Pt had a hemi arthroplasty 7 weeks ago and has a strong link to substance abuse & had a fall & fractured.Dr jenkins replaced the components & re-cemented the stem.Doi: unknown; dor: (b)(6) 2021; unknown side.
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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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.
Event or Problem Description
A.Please kindly provide the lot numbers for c-stem amt sz1 hi offset (157014070), articul/eze ball 28 +8.5 bl (136513000), self cent hip 47x28 brn (103547000) unfortunately i do not have the lot numbers in my records.B.What is the affected side involved in this event? the left side was the affected side.

• Brand Name: C-STEM AMT SZ1 HI OFFSET
• Common Device Name: C-STEM HIP IMPLANT : 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 dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13175934
• Report Number: 1818910-2022-00307
• Device Sequence Number: 4857631
• Product Code: KWA
• UDI-Device Identifier: 10603295060284
• UDI-Public: 10603295060284
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-14-070
• Device Catalogue Number: 157014070
• 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: 12/21/2021
• Supplement Date Received by Manufacturer: 01/12/2022; 02/04/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/20/2022; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 +8.5 BL; C-STEM AMT SZ1 HI OFFSET; SELF CENT HIP 47X28 BRN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 74 KG