MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 28 -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302803
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that this complaint reports an unspecified post-operative condition.No clinical information has been provided.However the two x-rays provided were analyzed.A review of the x-ray revealed,¿ there is a large cement mantel around the stem.And there appears to be loosening of the stem with radiolucency, and stress shielding of the greater trochanter.¿ however, the root cause of the reported condition cannot be determined due to the lack of clinical information.Therefore, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HD 28 -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7262563
• Report Number: 1020279-2018-00158
• Device Sequence Number: 16440426
• Product Code: LPH
• UDI-Device Identifier: 03596010194121
• UDI-Public: 03596010194121
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 06/12/2018

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: Lay User/Patient
• Device Catalogue Number: 71302803
• Device Lot Number: 09GM16744
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/11/2018
• Supplement Report FDA Received Date: 06/13/2018
• 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: 82 YR