MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH STR 190MM +15 CALCAR SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71927979
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) 2019, a broken echelon stem was revised and explanted.Redapt stem was implanted on the same date.No pieces fell into the patient and explanted stem will not be returned.Photo is attached.No more information available.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, the x-rays provided indicate possible micromotion of the proximal stem and likely resulting fatigue stress fracture but based on the limited information provided and without the return of the device for evaluation this root cause of the reported broken echelon stem cannot be confirmed.The impact to the patient beyond the revision cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.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 part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: ECH STR 190MM +15 CALCAR SZ 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8628223
• Report Number: 1020279-2019-02003
• Device Sequence Number: 16636339
• Product Code: JDI
• UDI-Device Identifier: 03596010475848
• UDI-Public: 03596010475848
• Combination Product (Y/N): N
• PMA/510(K) Number: K963486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 71927979
• Device Lot Number: 11BM01761
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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