MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	75100467
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stem of hip came loose, stem was revised.
Additional Manufacturer Narrative
Results of investigation: it was reported that a hip stem came loose.The stem complained about is a polarstem stem std.Ti/ha size 4 [article no.75100467] and was implanted with a oxinium head [article no.7134320c].No medical documents were received for investigation.Therefore no medical assessment can be performed.Should clinical documentation become available, the clinical/medical investigation may be re-evaluated.Aseptic loosening or a development of an osteolysis is a known possible side effect of joint replacement surgeries and is described in the ifu hip 12.23.The reported batch number b1610095 does not exist, the number was corrected.Due to the dhr/batch record with correct batch number b1610098, no deviations according to specification were found.For the corrected batch number no other complaint exists.The article complained about was not send back, a product evaluation could not have been done.The root cause remains undetermined and further investigations are not planned at that time.
Event or Problem Description
It was reported that the stem of the hip came loose and was revised.No additional information was made available.

• Brand Name: POLARSTEM STEM STD TI/HA 4 NON-CEM
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 8364854
• Report Number: 9613369-2019-00013
• Device Sequence Number: 11312296
• Product Code: LZO
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 06/29/2023
• Device Catalogue Number: 75100467
• Device Lot Number: B1610098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/24/2019
• Supplement Report FDA Received Date: 07/04/2019
• 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: PN: 7134320C OXINUIM FEMORAL HEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention