MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 3 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,

Model Number	75100476
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a size 3 stem was extremely easy to knock in.Surgeon had to upsize to size 4 stem which matched the trial more closely.Delay no greater than 30 minutes was recorded.
Additional Manufacturer Narrative
It was reported that a polarstem size 3 lat ti/ha does not match with the corresponding trial and a bigger size had to be used.The claimed article, which intended use is in treatment, was sent back for investigation.The returned stem was visually analyzed.There weren't any deformation or abnormalities detectable.Furthermore the returned stem was dimensional inspected.The sections for size identification were measured, all measurements are in spec.No other complaint found for the reported batch number.There's a risk which mentions a possibility of a backlash more than 1mm between rasp and stem, which could lead to an improper bone growth or instability of the stem by implanting.The risk considered to be low by s+n.No deviation found in the corresponding batch record.The stem was measured according to specification and no dimensional abnormalities was determined.There's no indication that the stem did not match the specification at time of manufacturing.After these investigations the root cause for the reported failure remains undetermined.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 3 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9511508
• Report Number: 9613369-2019-00108
• Device Sequence Number: 18937726
• Product Code: LZO
• UDI-Device Identifier: 07611996118674
• UDI-Public: 07611996118674
• Combination Product (Y/N): N
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 06/18/2026
• Device Model Number: 75100476
• Device Catalogue Number: 75100476
• Device Lot Number: B1913042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR