MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM; PROSTHESISHIPSEMICONSTRAINEDMETALCERAMICPOLYMERCEMENTEDORNONPOROUSUNCEMENTED

Model Number	75100467
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for a thr surgery, the inner packaging of the polarstem stem std ti/ha 4 non-cem was open even though the outer packaging was completely sealed.As this was noticed before procedure, there was not any patient involved.
Additional Manufacturer Narrative
H3, h6: it was reported that, during set up for a total hip replacement surgery, the inner packaging of the polarstem stem std ti/ha 4 non-cem was open even though the outer packaging was completely sealed.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported complaint issue could be confirmed.The primary peel-pouch is torn at the sealed area.The peel pouch shows signs of scratches due to implant movement.Furthermore, the folding box is deformed.The relationship between the reported event and the device was therefore confirmed.A complaint history review was performed.No additional complaint for the batch in scope was reported so far.The production documentation at the internal production as well as at the external packaging supplier site was reviewed.No deviations from the standard manufacturing procedure were detected.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The risk of a broken device packaging is covered in our corresponding risk file and rated as low.Furthermore, a review of past corrective actions was performed.There are no capa, pra/hhe, field actions related to the reported issue.In our current instruction for use for hip implants lit.12.23 ed.03/21 it is mentioned that the device should not be used if the packaging shows any damage.The external packaging supplier performed a thorough product evaluation.According to the performed investigations, there is no indication that the device failed to meet packaging specifications upon release for distribution.The most probable root cause is that there was an external force (e.G.The folding box falling to the floor) deforming the folding box and exceeding the fixing force of the vacuumation.The packaging supplier assumes that the distal stem then damaged the sealing seam of the peel pouch due to this external force.After this initial damage and loss of vacuumation, the stem could move around and create further scratches on the inside of the primary peel-pouch.However, based on the performed investigations, this root cause cannot be confirmed conclusively and remains therefore unknown.No further actions are deemed necessary.Smith and nephew will monitor this device for similar issues.This investigation is considered closed.The returned device will be discarded.

• Brand Name: POLARSTEM STEM STD TI/HA 4 NON-CEM
• Common Device Name: PROSTHESISHIPSEMICONSTRAINEDMETALCERAMICPOLYMERCEMENTEDORNONPOROUSUNCEMENTED
• 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: 14352657
• Report Number: 9613369-2022-00258
• Device Sequence Number: 4866261
• Product Code: LZO
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 75100467
• Device Catalogue Number: 75100467
• Device Lot Number: C2140459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown