MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTH, HIP, SEMI-CONSTRAINED, UNCEM, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71291302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stem broke inside the patient.Patient complained of pain and the stem was revealed to be broken in x-ray.A revision surgery was performed due to this incident.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the x-ray provided confirms the break and demonstrates lack of bony support of the stem at the greater trochanter likely due to stress shielding.This could have played a role in the eventual failure of the stem 9 years later.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported broken 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 complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: EMP 13 STEM PRIMARY HO
• Common Device Name: PROSTH, HIP, SEMI-CONSTRAINED, UNCEM, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8834704
• Report Number: 1020279-2019-02818
• Device Sequence Number: 2877134
• Product Code: MEH
• UDI-Device Identifier: 03596010561497
• UDI-Public: 03596010561497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 71291302
• Device Lot Number: 10CM12688
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/28/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 134