MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. RALLY HV AB BONE CEMENT 40 GRAMS

Catalog Number	71271570
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	09/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was found to have poor range of motion and experiencing more pain than expected.An aspiration was performed to rule out infection.
Additional Manufacturer Narrative
The associated complaint device were not returned.A clinical evaluation was conducted and based on the information provided the root cause of the poor range motion captured in (b)(4).Multiple fall history captured in ((b)(4)), and the left knee arthrofibrosis captured in (b)(4), could not definitively be determined.However, the reported non-compliance, chronic opioid usage, morbid obesity(weighing 260.7 pounds), and fall history cannot be ruled out as contributory factors to the reported issues.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted 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.We consider this investigation closed.

• Brand Name: RALLY HV AB BONE CEMENT 40 GRAMS
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7927866
• Report Number: 1020279-2018-01992
• Device Sequence Number: 19332493
• Product Code: LOD
• UDI-Device Identifier: 00885556582220
• UDI-Public: 00885556582220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: No Information
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 71271570
• Device Lot Number: 15LTC0014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 05/08/2019
• 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
• Patient Age: 48 YR