MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100464
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Unequal Limb Length (4534)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after daa tha surgery, the patient was in pain from the second week and onwards, felt tight across the front hip, did not had a good range of movement and the leg on the operative side was shorter.A revision surgery was performed on (b)(6) 2021 and all the components were explanted.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that, after daa tha surgery, the patient was in pain from the second week and onwards, felt tight across the front hip, did not had a good range of movement and the leg on the operative side was shorter.A revision surgery was performed on (b)(6) 2021 and all the components were explanted.The patient outcome is unknown.The claimed article a polarstem stem std ti/ha 1 non-cem [article no.: (b)(4); batch no.: b2004208], which intent use is in treatment.The device was not returned for investigation.In our batch record no deviations found.Due to the mentioned migration of the stem and the assumption that the stem could have been subsided, the measuring protocols were reviewed as well but no discrepancies were found.It will not assumed that the device failed due to manufacturing.The instruction for use for hip implants (lit.No.(b)(4)) lists "dislocation, subluxation, insufficient range of movement, undesirable shortening or lengthening of the limb, as well as repositioning of the implant" among the possible side effects resulting from total hip arthroplasty.The risk of an implant migration is also covered in our corresponding risk file and rated as low.The provided x-rays were reviewed.However, the events related to the complaint are unclear.On the provided images only the right side appears to have an implant.The left side appears to be planning pre-op for a left sided procedure.Therefore we can¿t make any conclusions from the left sided pre-op planning.Smith and nephew has not received the explanted devices and it is noted no additional information is available.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.To date and after reviewing all received information and documentation a relationship between the device and the reported event is not given.The failure mode can not be independently confirmed.The root cause can not be established and no potential contributing factor can be identified.S+n will monitor this device for similar issues and will re-assessed further investigation if additional information or documentation get available.

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11825660
• Report Number: 9613369-2021-00218
• Device Sequence Number: 4243106
• Product Code: LZO
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• 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
• Report Date (Section B): 07/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B2004208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 07/08/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/09/2021; 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention