MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 32 + 0; PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEME

Model Number	71303200
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to multiple dislocations.Liner and head were exchanged.In addition to this the patient presented 5 dislocations on the dates: (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017 these were treated with closed reductions.The doctor sent a letter to the patient stating that the femoral component used on the first revision surgery was mislabeled and it was a 32mm rather than a 28mm.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms it cannot be ruled out the mislabeled femoral head and the signs and symptoms such as twisting and stepping wrong reported by this patient likely contributed to the dislocation that lead to a subsequent revision.The reported issue with the femoral head mispack has been addressed under a recall and hhe for the femoral head mispack.The impact to the patient according the clinic notes at one-year follow this patient dislocated again and underwent a subsequent closed reduction (captured under (b)(4)).No further clinical/medical 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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.A review of the risk management file and instructions for use document for this failure mode was conducted.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The probable cause for this event is a manufacturing process error.Based on this investigation, corrective and preventive action is indicated to mitigate future recurrence of similar events.Without the actual product involved, 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: COCR 12/14 FEM HD 32 + 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEME
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9520218
• Report Number: 1020279-2019-04599
• Device Sequence Number: 2751363
• Product Code: LPH
• UDI-Device Identifier: 03596010194176
• UDI-Public: 03596010194176
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2021

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: No Information
• Device Model Number: 71303200
• Device Catalogue Number: 71303200
• Device Lot Number: 17AM14045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 05/21/2020; 08/24/2021
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 05/26/2020; 08/24/2021
• 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: Required Intervention