MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRIM HO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain and bone loss.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the documentation provided, currently unable to rule out the neutral and vertical version of the primary socket/acetabular component as a possible contributing factor to the known potential complications of femoral stem loosening, osteolysis and pain.Probable micro-motion and the heterotopic ossification also most likely contributed to the reported pain.(b)(6)).In addition to the violation of the posterior hip precautions/traumatic event at approximately 6 weeks of the 1st revision, the previously identified neutral/vertical version along with off-label use/mixed components could have also been a contributing factor to the reported recurrent instability (b)(6).The patient impact beyond the reported symptoms and revisions cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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: SPEC EF PRIM HO 12/14 SZ 2
• 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: 8904438
• Report Number: 1020279-2019-03086
• Device Sequence Number: 18903429
• Product Code: JDI
• UDI-Device Identifier: 03596010195579
• UDI-Public: 03596010195579
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 04/13/2018
• Device Catalogue Number: 71312112
• Device Lot Number: 08DM13101
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 08/18/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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