MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM AMT SZ1 STD OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	1570-04-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/20/2021
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
I attended surgery today for a revision hip case where a c-stem amt primary was replaced (due to stem fracture) with a reclaim.This was scheduled revision surgery so no implications for extended surgery time.Primary surgery details - surgery date: (b)(6) 2015; revision surgery details - surgery date: (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.Visual examination of the provided x-ray image confirmed the reported event.The femoral stem was fractured.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: C-STEM AMT SZ1 STD OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12582624
• Report Number: 1818910-2021-22068
• Device Sequence Number: 14296789
• Product Code: KWA
• UDI-Device Identifier: 10603295059592
• UDI-Public: 10603295059592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 09/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 1570-04-070
• Device Catalogue Number: 157004070
• Device Lot Number: D15101931
• 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: 09/20/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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; C STEM VOID CENTALIZER 12 DM; C-STEM AMT SZ1 STD OFFSET; DEPUY CMW 2G 40G; MARATHON XLPE CEMENT CUP 28/45; MARATHON XLPE CEMENT CUP 28/45; ARTICUL/EZE BALL 28 +12 BLK; C STEM VOID CENTALIZER 12 DM; C-STEM AMT SZ1 STD OFFSET; DEPUY CMW 2G 40G; MARATHON XLPE CEMENT CUP 28/45; MARATHON XLPE CEMENT CUP 28/45
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male