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
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2021-00326
• Device Sequence Number: 19793728
• Product Code: LWJ
• UDI-Device Identifier: 07611996118629
• UDI-Public: 07611996118629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1