MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 5 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100478
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the box of a polarstem stem lat.Ti/ha 5 non-cem must have taken a beating at some point in time.There was an indentation in the lower portion of the box, and there was a hole in both of the inner wrappings, so the implant was not sterile.As this happened in a non-surgical environment, there was not patient involvement.
Additional Manufacturer Narrative
It was reported that the packaging of a polarstem stem lat.Ti/ha 5 non-cem must have taken a beating at some point in time.There was an indentation in the lower portion of the box, and there was a hole in both of the inner-most peel bags.As this happened in a non-surgical environment, there was no patient involved.The claimed article, used in treatment, was returned for investigation and the reported failure mode can be confirmed.The innermost peel-bag shows some heavy signs of stem movement due to a loss of vacuum.The surface is scratched and a hole is visible in the distal sealed area.The production records were reviewed, however no discrepancies in these records were recognized.Additionally, no other complaint was reported for the batch in scope.There's no indication that the device failed to match specification at time of distribution.Review of past corrective actions was performed.No further escalation is required.The risk of a tear, rip or hole in the device packaging is covered within our sterility packaging risk file and rated as low.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.03/21) 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 or 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 5 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 TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12509737
• Report Number: 9613369-2021-00369
• Device Sequence Number: 3255547
• Product Code: LZO
• UDI-Device Identifier: 07611996118698
• UDI-Public: 07611996118698
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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 Expiration Date: 01/06/2023
• Device Model Number: 75100478
• Device Catalogue Number: 75100478
• Device Lot Number: B1600303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown