MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 0 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100463
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr the oxinium fem hd 12/14 36 mm +0 broke near the distal tip.It was necessary revision surgery in order to extract the distal tip and this was incredibly difficult.It required an eto and cables.A redapt stem x 240mm was implanted.The patient was not injured beyond the described event.No other complications were reported.
Additional Manufacturer Narrative
It was reported that after a total hip replacement the polarstem stem std ti/ha 0 non-cem broke near the distal tip.A revision surgery was conducted in order to extract the distal tip.The product which intent use is in treatment, was not returned for investigation.A production history review was performed.The batch record was reviewed but did not reveal any deviation which could explain the occurred breakage of the stem.For the batch in scope no other complaint was recorded.Due to the review of the production record it can be stated that the device met the specification at the time of manufacturing.The provided single undated/unidentified x-ray photocopy appears to show significant proximal femoral lucency, along with the distal 1/3 stem fracture which supports the complaint.There is cortical thickening around the stem to indicate that there may have been some loosening at some point during its time implanted and may account for the distal stem breakage.Without comparison images subsidence cannot be assessed but it could have played a role as well.Based on the available information it is not possible to speculate about factors which could have contributed to the reported event the risk of an implant fracture is known and mentioned in our current instruction for use for hip implants as well as in our risk file, where it is rated as low.To date and after the performed investigation, no conclusion can be made.The reported failure can be confirmed and a relationship between product and reported event exists.The root cause of the fracture stays undetermined.Should additional clinical documentation or the device itself become available in the future, the clinical/medical task and further investigations will be conducted.In the meantime, s+n will monitor this device for similar issues.
Additional Manufacturer Narrative
It was reported that after a total hip replacement the polarstem stem std ti/ha 0 non-cem [article no.: 75100463; lot no.: b1919292] broke near the distal tip.A revision surgery was conducted in order to extract the distal tip.The product which intent use is in treatment, was not returned for investigation.A production history review was performed.The batch record was reviewed but did not reveal any deviation which could explain the occurred breakage of the stem.For the batch in scope no other complaint was recorded.Due to the review of the production record it can be stated that the device met the specification at the time of manufacturing.The provided single undated/unidentified x-ray photocopy appears to show significant proximal femoral lucency, along with the distal 1/3 stem fracture which supports the complaint.There is cortical thickening around the stem to indicate that there may have been some loosening at some point during its time implanted and may account for the distal stem breakage.Without comparison images subsidence cannot be assessed but it could have played a role as well.Based on the available information it is not possible to speculate about factors which could have contributed to the reported event the risk of an implant fracture is known and mentioned in our current instruction for use for hip implants [lit.12.23, ed.05/16] as well as in our risk file, where it is rated as low.To date and after the performed investigation, no conclusion can be made.The reported failure can be confirmed and a relationship between product and reported event exists.Nevertheless no corrective and preventive actions are planned at this time.The root cause of the fracture stays undetermined.Should additional clinical documentation or the device itself become available in the future, the clinical/medical task and further investigations will be conducted.In the meantime, s+n will monitor this device for similar issues.
Additional Manufacturer Narrative
H3, h6: it was reported that after a total hip replacement the polarstem stem std ti/ha 0 non-cem broke near the distal tip.A revision surgery was conducted in order to extract the distal tip.The product which intent use is in treatment, was returned for investigation.The fracture of the polarstem in the distal area of the stem can be confirmed.Both parts of the stem show scratches and peeled off coating which most likely originate from removing the stem during the reported revision surgery.A material assessment showed that the stem fractured due to fatigue.No deviations in the material composition could be observed.Based on these findings, the relationship between the device and the reported event can be confirmed.A production history review was performed.The batch record was reviewed but did not reveal any deviation which could explain the occurred breakage of the stem.For the batch in scope no other complaint was recorded.Due to the review of the production record it can be stated that the device met the specification at the time of manufacturing.The provided single undated/unidentified x-ray photocopy appears to show significant proximal femoral lucency, along with the distal 1/3 stem fracture which supports the complaint.There is cortical thickening around the stem to indicate that there may have been some loosening at some point during its time implanted and may account for the distal stem breakage.Without comparison images subsidence cannot be assessed but it could have played a role as well.These might be contributing factors, however the root cause for the fracture of the stem stays undetermined.The risk of an implant fracture is known and mentioned in our current instruction for use for hip implants [lit.12.23, ed.05/16] as well as in our risk file, where it is rated as low.Review of past corrective actions was performed.No further escalation is required.To conclude, the root cause of the fracture stays undetermined.To date, further actions shall not be initiated.Should additional clinical documentation become available in the future, the investigation will be reopened.S+n will monitor this device for similar issues.The returned device will be retained.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
This report was inadvertently submitted under manufacturer number 1020279, the correct manufacturer number is 9613369.

• Brand Name: POLARSTEM STEM STD TI/HA 0 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 11744276
• Report Number: 1020279-2021-03695
• Device Sequence Number: 4176258
• Product Code: LWJ
• UDI-Device Identifier: 07611996118544
• UDI-Public: 07611996118544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2026
• Device Model Number: 75100463
• Device Catalogue Number: 75100463
• Device Lot Number: B1919292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 07/09/2021; 04/20/2022; 04/27/2022
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/22/2021; 07/09/2021; 04/22/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown