MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 08/17/2020

Event Type  Injury  

Event Description

It was reported that, after a tha procedure had been performed, the hip dislocated.A revision surgery was performed to address the adverse event.There was no loosening of the polarstem, just a longer neck was required.Surgeon decided to remove stem and use a cemented stem.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed due to a hip dislocation.There was no loosening of the stem, just a longer neck was required.The claimed article is a polarstem stem standard 3 cemented, which intent use is in treatment, was not sent back for investigation.No clinical documentation got available.The reported failure can not be determined.In the corresponding production records no deviations were found which could explain the reported failure.No other similar complaint could be found for the specific article.The risk of a dislocation is mentioned in our specific risk file.Furthermore in our current instruction for use for hip implants 12.23 ed.05/16 dislocation is a mentioned side effect of a total hip endoprosthesis.At that time of investigation the root cause can not be determined.If further information should get available this case will be re-assessed.S+n will monitor this device for similar issues.

• Brand Name: UNKN. POLARSTEM CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• MDR Report Key: 10526086
• MDR Text Key: 206720594
• Report Number: 9613369-2020-00176
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K143739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/12/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention