MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100474
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient suffered from an event first month after primary surgery.At this time, surgeon reviewed x-rays and felt that there had been a small amount of subsidence since immediate post op x-rays were taken.It was identified that the distal tip of the stem on primary implantation had possibly rested upon an area of sclerotic bone change within the canal.Surgeon and patient decided to see if the discomfort would settle and review after christmas/new year period.The discomfort didn't settle and more x-rays were ordered, a lesion was visible at the level of the distal tip of stem and the stem had noticeably subsided to the level of the bottom of this lesion.The surgeon felt the stem was loose and not likely to integrate at this point, and it was decided to undertake a stem revision.Primary surgery was on (b)(6) 2020.
Additional Manufacturer Narrative
Investigation results: it was reported, that the surgeon detected a small amount of stem subsidence within the first month after initial surgery.It was identified that the distal tip of the stem on primary implantation had possibly rested upon an area of sclerotic bone change within the canal.As the discomfort of the patient did not settle, a revision surgery was conducted to remove the stem.The device, used in treatment, was not returned for investigation.The production documentation was reviewed.There are no indications that the device failed to match specification at the time of manufacturing.Furthermore, no further complaint was reported for the batch in scope.The failure mode and the severity are covered through our risk management files.The ifu (lit.No.12.23, (b)(6) lists "dislocation, subluxation, insufficient range of movement, undesirable shortening or lengthening of the limb" among the possible side effects resulting from total hip arthroplasty.A medical investigation was not conducted, as no adequate material was returned for investigation.The reported failure mode could not be independently confirmed.The root cause is attributed to a known inherent risk from a total hip arthroplasty.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this complaint for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 1 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: 11320819
• Report Number: 9613369-2021-00069
• Device Sequence Number: 19865129
• Product Code: LWJ
• UDI-Device Identifier: 07611996118650
• UDI-Public: 07611996118650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75100474
• Device Catalogue Number: 75100474
• Device Lot Number: B2005707
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM HEAD 71343600, 20CM24274; OXINIUM HEAD 71343600, 20CM24274
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention