MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 49OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED UNCEMENTED

Catalog Number	71324049
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Unexplained pain in lateral trochanteric region.Possibly associated with a significant loss of offset in the joint post primary surgery.Surgeon began dissecting down to hip joint.On approach to the hip joint a trochanteric soft tissue mass was identified.According to surgeon is was probably calcific tendonopathy associated with loss of function as result of the reduced offset in the hip after the primary surgery.The area was extremely inflamed with some minor bleeding over and around the site.The calcification deposit was debrided.Hip joint opened.Dislocated hip.Tapped off bipolar head with bone punch.Removed cement from around shoulder of the stem.Stem removed with renovation slap hammer.Mantle within canal assessed and deemed appropriate for cement in cement revision of stem.Acetabulum prepared for corin trinity shell.Shell impacted and liner inserted.Size 1 high offset stem cemented into existing mantle within proximal femur.Construct trialled and deemed stable.Definitive head implanted into the stem.Hip reduced.Wound closed.
Additional Manufacturer Narrative
The affected tandem intl cocr shell liner bipolar was not returned for evaluation.A clinical evaluation noted based on the limited information provided, the root cause of this patient¿s pain cannot be concluded, and if the cup position and if any impingement is present along with the reported calcification deposits.However, it could be attributed to the ¿calcific tendinopathy associated with loss of function as result of the reduced offset in the hip after the primary surgery¿.It has been communicated that no further information would be forthcoming at this time.A review of the manufacturing records for the listed batch 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 product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: TANDEM INTL BIPOLAR 49OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7329701
• Report Number: 1020279-2018-00294
• Device Sequence Number: 1605175
• Product Code: KWY
• UDI-Device Identifier: 03596010494405
• UDI-Public: 03596010494405
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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 Expiration Date: 10/13/2024
• Device Catalogue Number: 71324049
• Device Lot Number: 14KM11166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/11/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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