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

Catalog Number	101012100
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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.
Event or Problem Description
Der states that upon opening the implant, the scrub tech noticed that there was a hair on the blue packaging that encases the stem.It was also reported that another stem was readily available and the contaminated stem was passed off.It was believed that it was contaminated during packaging process.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned product is not able to confirm the reported observation.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. .
Event or Problem Description
Complaint description: der states that upon opening the implant, the scrub tech noticed that there was a hair on the blue packaging that encases the stem.It was also reported that another stem was readily available and the contaminated stem was passed off.It was believed that it was contaminated during packaging process./ | investigation method: / | investigation summary:.

• Brand Name: ACTIS COLLARED HIGH SIZE 10
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7013342
• Report Number: 1818910-2017-28407
• Device Sequence Number: 13484263
• Product Code: KWL
• UDI-Device Identifier: 10603295380627
• UDI-Public: 10603295380627
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: H22777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR