MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 8 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75100471

Device Problems Tear, Rip or Hole in Device Packaging (2385); Scratched Material (3020)

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

Event Date 07/12/2021

Event Type  malfunction  

Event Description

It was reported that, during a tha, a polarstem stem standard ti/ha 8 non-cem was not packaged securely, which caused the stem's coating to scratch off with the plastic.The procedure was completed without delay using a smith and nephew back up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

It was reported that, during a tha, a polarstem stem standard ti/ha 8 non-cem was not packaged securely, which caused the stem's coating to scratch off with the plastic.The procedure was completed without delay using a smith and nephew back up device.Patient was not harmed as consequence of this problem.The claimed article, which intent use is in treatment, including packaging was returned for investigation.The failure mode of a compromised innermost sterile barrier can be confirmed.The stem isn't fixed proper any more, and the inside of the bag shows several scratches evoked due the moving of the stem.The production records were analyzed, no deviations were found which could explain the occurred failure.For the batch in scope no other complaint was recorded.There is no indication that the device failed to match specification at the time of manufacturing.In our current ifu for hip implants lit.12.23 ed.05/16 it is stated that a device which packaging shows any damage shouldn't be used.The risk is covered within our product related risk file.To date no corrective or preventive actions are planned.The batch in scope was part of a loaner set.As contributing factor it can be named that repeated stock manipulations may have contributed to the motion of the stem inside the packaging causing the observed vacuum loss.Nevertheless the root cause can not be clearly established and remains undetermined.Smith and nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 8 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12239439
• MDR Text Key: 263874711
• Report Number: 9613369-2021-00326
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118629
• UDI-Public: 07611996118629
• Combination Product (y/n): N
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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 Model Number: 75100471
• Device Catalogue Number: 75100471
• Device Lot Number: B1924257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1