MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 563517

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that after taking the shrink wrap plastic off the box, i opened the box.Inside was implant with the outer packaging already opened and not sealed.

Manufacturer Narrative

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. .

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 review: 15 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.Per the sterilization certificate, the sterilization cycle met the validated parameters.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Updated july 03, 2019 examination of the returned device and packaging materials confirms the outer carton and one of two interior packaging sleeve components is open.The inner of the two remains sealed, no breach is identified.There is no evidence to indicate the device was distributed in the returned condition.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 : 9033990.Device history batch : null.Device history review : 15 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.Per the sterilization certificate, the sterilization cycle met the validated parameters.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM STM ST,36+6L NK,11X16X150
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8432683
• MDR Text Key: 139206018
• Report Number: 1818910-2019-87756
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 563517
• Device Lot Number: 9033990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 04/12/2019; 04/17/2019; 07/10/2019
• Supplement Dates FDA Received: 04/12/2019; 05/10/2019; 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR