MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG 58/28MM BH DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	74121658
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a 58mm dual mobility liner instead of a 50mm (min) or 52mm (max) liner/head.
Additional Manufacturer Narrative
It was reported that a patient was incorrectly implanted with a 58mm dual mobility insert instead of a 50mm (minimum) or 52mm (maximum) insert.The implanted devices were all used in treatment.As of today, device return and additional information has been requested for this complaint but have not become available.A review of the complaint history for the dual mobility insert was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the device reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu and surgical technique found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.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.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.A root cause of user error has been selected as sizing and compatibility details included within the ifu and surgical technique were not followed.If the products or additional information become available in the future, this case will be re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: 58/28MM BH DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5000 ; SZ 5000
• MDR Report Key: 8436970
• Report Number: 3005975929-2019-00142
• Device Sequence Number: 1795907
• Product Code: LPH
• UDI-Device Identifier: 00885556577288
• UDI-Public: 00885556577288
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: 74121658
• Device Catalogue Number: 74121658
• Device Lot Number: A1718614
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other