MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339152
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Joint Dislocation (2374)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation in spastic patient.There were revised liner and femoral head.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, visual inspection of the constrained outer polyethylene liner revealed scratches and dents on the spherical od, scratches and dents on the rim of the inner and outer poly, and damaged areas on the locking scallops.It is unclear how these blemishes occurred based on the information given.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.The clinical/medical team concluded, based on the surgeon¿s statement, the root cause of the patient multiple dislocations was likely due to contractions-patient is spastic.However, without the requested clinical information, radiographs, implantation operative report, fall history we cannot rule an unlocked liner, non-compliance, bone quality, altered mental status, age, activity prior to full bone union as possible contributing factors.The future impact to the patient beyond the revision cannot be determined.No further clinical medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: R3 CONST 52MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8074222
• Report Number: 1020279-2018-02496
• Device Sequence Number: 11185703
• Product Code: KWZ
• UDI-Device Identifier: 00885556022443
• UDI-Public: 00885556022443
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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 Catalogue Number: 71339152
• Device Lot Number: 17KM09109A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 03/06/2019
• 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