MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 8 NON-CEM; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS

Model Number POLARSTEM STEM LAT.TI/HA 8 NON-CEM

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2020

Event Type  malfunction  

Event Description

It was reported that during a hip tep implantation, when unpacking and presenting the polarstem, it was found that the stem was unsterile.Then surgeon's decision was to implant avenir stem from zimmer, at the same time the r3 cup was removed and an allofit cup from zimmer was implanted.

Manufacturer Narrative

Results of investigation: it was reported that during a hip tep implantation, when unpacking and presenting the polarstem, it was found that the stem was unsterile.The product was sent back for investigation.The tip of the stem is pierced through all three sterile barriers and slight scratches can be seen in the innermost peel bag on the location of the stem.The batch record review did not reveal any deviation which could lead to the reported failure.For the reported batch number no other complaint can be found, since manufacturing of the batch back in 2017.Repeated stock manipulations may have contributed to the motion of the stem inside the packaging causing the observed sterility breach.According to our instructions for use (ifu lit.No.12.23 ed.05/16) implants may not be implanted under any circumstances if the packaging is damaged or not intact.Peel pouches showing scratches or significant migration of the stem towards the sealed seams as well as stems observed to move freely inside the peel pouches should therefore be considered as unfit for use.If this scenario occurs, we kindly ask you to return the affected products (the peel pouches and the corresponding stems) to the appropriate smith & nephew representative or office for investigation.This complaint will be closed.Smith&nephew will however continue to monitor the corresponding products for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 8 NON-CEM
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10171768
• MDR Text Key: 195743670
• Report Number: 9613369-2020-00119
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: POLARSTEM STEM LAT.TI/HA 8 NON-CEM
• Device Catalogue Number: 75100481
• Device Lot Number: B1704767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN R3 SHELL
• Patient Outcome(s): Required Intervention