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

Model Number	75100474
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had periprosthetic hip fracture and a loose stem.A revision surgery was performed to resolve the event.
Additional Manufacturer Narrative
A revision surgery was reported due to periprosthetic fracture.The device revised was a polarstem cementless lat stem ti/ha size 1 which was used for treatment and was not sent back for investigation.Furthermore no clinical documentation have been received.Therefore a thorough product or medical investigation could not be performed.The batch records did not reveal any deviation which could have led to the reported failure.No other complaint was found for the reported batch.Bone fracture is a known risk for s+n and is mentioned in the corresponding ifu for hip implants (b)(6) - ed.(b)(6).At that time of investigation the root cause remains undetermined.Should medical/clinical records being received, the complaint will be re-opened.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM CEMENTLESS STEM LAT TI.HA 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9489013
• Report Number: 9613369-2019-00105
• Device Sequence Number: 16889391
• Product Code: LZO
• UDI-Device Identifier: 07611996118650
• UDI-Public: 07611996118650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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 Expiration Date: 07/02/2026
• Device Model Number: 75100474
• Device Catalogue Number: 75100474
• Device Lot Number: B1914212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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: HEAD: 76539166, LOT 19HT26346; HEAD: 76539166, LOT 19HT26346
• Outcome Attributed to Adverse Event: Required Intervention