MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 6 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100479
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, it was noticed that the polarstem stem lat.Ti/ha 6 non-cem came with the packaging open.In order to use it, it had to be sterilized again.The surgery was completed, after a delay greater than 30 min, with the same reported device.No injuries were reported.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, during a total hip replacement surgery, it was noticed that the polarstem stem lat.Ti/ha 6 non-cem came with the packaging open.In order to use it, it had to be sterilized again.The surgery was completed, after a delay greater than 30 min, with the same reported device.The device used in treatment was not returned for investigation as it was re-sterilized and implanted.The package of this device has not being returned neither.A visual evaluation was performed on one image provided by the complainant, and it showed that the polarstem stem lat.Ti/ha 6 non-cem in the picture has the neck cover on it.The peel pouch shows scratches which are probably originated by the micromotion of the stem inside it.The sealed end of the peel pouch displays a hole on it, which matches with the tip size and shape of the distal end of the stem.Possible cause of the damaged surface is the increased friction and the transportation which may have damaged the film and the sealed end, so that most likely the vacuum has been released as a result, permitting more internal motion of the stem and the first pouch hole.A complaint history review was performed.No additional complaint was detected for the batch in question.Furthermore, the production documentation at the internal production as well as at the external packaging supplier site did not reveal any deviations which could have contributed to the underlaying issue.There is no indication that the device failed to match specification at the time of manufacturing.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.As part of the continuous improvement, smith+nephew is planning a packaging design enhancement.No further escalation is required.The instructions for use (lit.No.12.23, ed.03/21) states "implants provided as sterile must not be resterilised by the purchaser." in the section ¿cleaning, disinfection and sterilisation/resterilisation¿, in regards with the implantation of a hip prosthesis.To conclude, based on the performed investigations, the alleged event could be confirmed.As contributing factor, repeated stock manipulations may have contributed to the motion of the stem inside the packaging causing the observed vacuum reduction, and later a hole on the sealed end.Nevertheless, the root cause cannot be clearly established and remains undetermined.To date, no corrective or preventive actions are planned.Smith and nephew will monitor this device for similar issues.Should additional information be received, the complaint will be reopened.Corrected data: d7a (although not reused in more than one patient, the device was reprocessed and used contrary to the ifu indications).

• Brand Name: POLARSTEM STEM LAT.TI/HA 6 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19047302
• Report Number: 9613369-2024-00032
• Device Sequence Number: 18284021
• Product Code: LZO
• UDI-Device Identifier: 07611996118704
• UDI-Public: 07611996118704
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Catalogue Number: 75100479
• Device Lot Number: C2203339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/30/2024
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown