MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-132
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
When scout nurse opened outer box for implant (b)(4) lot 69672005 it was noticed that the inner pack appeared to be marked.Shown to operating surgeon and decided not to use this implant and opened another implant with same cat number.Update 07 june, 2019: reporter confirmed a surgical delay of less than 2 minutes.Update: "the patient was in the o.R.At the time of discovery and was under anesthesia.
Additional Manufacturer Narrative
An event regarding foreign matter (smudge mark) involving a metal head was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: visual inspection: visual inspection confirmed a smudge mark to be on the inner packaging of the device.Material analysis, functional and dimensional inspections were not be performed as these aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: an nc was raised to investigate this event.There are no related nc's for similar issue prior to this nc.Based upon the nonconformance description and investigation, the user found damage on the packaging component.It was visible to surgery team and the unit was not used.An alternative device was available for use.This complaint has been deemed an isolated event.The compliance concern has been determined to be low.
Event or Problem Description
When scout nurse opened outer box for implant 6260-9-132 lot 69672005 it was noticed that the inner pack appeared to be marked.Shown to operating surgeon and decided not to use this implant and opened another implant with same cat number update 07 june, 2019: reporter confirmed a surgical delay of less than 2 minutes.Update: "the patient was in the operating room at the time of discovery and was under anesthesia.

• Brand Name: 32MM STD LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8748028
• Report Number: 0002249697-2019-02425
• Device Sequence Number: 1708167
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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 Expiration Date: 02/28/2024
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 69672005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other