MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ACTIS COLLARED HIGH SIZE 10; HIP FEMORAL STEM

Catalog Number	101012100
Medical Device Problem Codes	Fitting Problem (2183); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
Broach and implant did not seem to match.Customer reference/po/service: (b)(4), was surgery delayed due to the reported event? yes, if yes, number of minutes: 10-15, action taken when event occurred? alternative implant used., was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, patient status/outcome/consequences? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown, ip-00512191: device property of? none, device in possession of? submitter.Ip-00512192: 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).Investigation summary = > related dimensional examination of the returned product found no discrepancy from drawing requirements.No product problem identified.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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.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).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.

• Brand Name: ACTIS COLLARED HIGH SIZE 10
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8444664
• Report Number: 1818910-2019-88204
• Device Sequence Number: 3056944
• Product Code: KWL
• UDI-Device Identifier: 10603295380627
• UDI-Public: 10603295380627
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K160907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101012100
• Device Lot Number: HP3993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 04/16/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/12/2019; 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR