MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS STD NK SZ8/9; FEMORAL STEM TRIALS

Catalog Number	201002500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
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
It was reported that the actis trial necks keep sliding off broaches.They called r.O in hip marketing and told they have fixed this issue in the newer sets.Needing to get three sets of trial necks for actis standard and high offset.R.O told him to fill out mdr form and i cld get older style actis necks replaced.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.The root cause is attributed to design.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory 248 reports that the actis trial necks keep sliding off broaches.They called r.O in hip marketing and told they have fixed this issue in the newer sets.Needing to get three sets of trial necks for actis standard and high offset.A functional check with a mating broach confirmed the complaint.A design change was implemented on (b)(6) 2017 via co 103322555.The hole diameter and tolerance along with the pin diameter were changed for a more constrained fit to the broach.Review of the as400 found this lot was placed into distribution in may 2018 indicating the instrument was manufactured after the design change.Depuy engineering is aware that the issue still exists and is currently reviewing the design.Complaints will be monitored under post market surveillance (b)(4).Device history lot : null.Device history batch : null.Device history review : null.

• Brand Name: ACTIS STD NK SZ8/9
• Common Device Name: FEMORAL STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9220435
• Report Number: 1818910-2019-111205
• Device Sequence Number: 19378936
• Product Code: KWL
• UDI-Device Identifier: 10603295393825
• UDI-Public: 10603295393825
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2019

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: 201002500
• Device Lot Number: PG277155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 10/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/07/2019; 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR