MAUDE Adverse Event Report: STRYKER GMBH PRESS-FIT HUMERAL STEM 13MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5567-P-3013

Device Problems Component Missing (2306); Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

T&e team received a femoral stem which was packaged in a box for a press-fit humeral stem.This event did not affect the outcome of the case.The stem box was labeled a shoulder reunion s stem but then inside the box was a hip stem.We realized this immediately and opened the correct size stem as we had backup implants for that case.As reported by rep, who was asked if the outer box was shrink wrapped, and if the stem was in an outer and inner sterile blister: "yes it was shrink wrapped.Stem was also in its sterile packaging correctly.Everything about the make up of the box and packaging was normal except for the stem inside being a hip stem instead of a reunion s shoulder stem as labeled.".

Event Description

T&e team received a femoral stem which was packaged in a box for a press-fit humeral stem.This event did not affect the outcome of the case.The stem box was labeled a shoulder reunion s stem but then inside the box was a hip stem.We realized this immediately and opened the correct size stem as we had backup implants for that case.As reported by rep, who was asked if the outer box was shrink wrapped, and if the stem was in an outer and inner sterile blister: "yes it was shrink wrapped.Stem was also in its sterile packaging correctly.Everything about the make up of the box and packaging was normal except for the stem inside being a hip stem instead of a reunion s shoulder stem as labeled.".

Manufacturer Narrative

The reported event could be confirmed, since in the or, a rep from the t&e division found a hip stem from the jr division (cat: 1601-09132, lot: n97p27) in a package of a reunion s stem (cat: 5567-p-3013, lot: g7785558).The labeling on the box clearly indicated specifics of the t&e reunion s product, but the contents (implant) was wrong, and contained a femoral stem from jr.An nc was opened to investigate the event further.Based on investigation, the root cause was attributed to a manufacturing related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: PRESS-FIT HUMERAL STEM 13MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16400462
• MDR Text Key: 309993562
• Report Number: 0008031020-2023-00090
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327424973
• UDI-Public: 07613327424973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5567-P-3013
• Device Catalogue Number: 5567-P-3013
• Device Lot Number: G7785558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1