LPS
Received Jul 27, 2026 · Event occurred Jul 6, 2026
Report 1818910-2026-12783 · MDR key 50045663
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
It was reported that patient was revised due to pain.DOI: Unknown.DOR: (b)(6 )2026.Affected Side: Right.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (b)(4).INVESTIGATION SUMMARY: No device associated with this report was received for examination. An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation. As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications. Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance. If additional information is made available, the investigation will be updated as applicable.DEVICE HISTORY LOT: The device lot number is unknown, therefore a¿Device History Review could not be performed.¿ If the lot/serial number becomes available, the record will be re-assessed.This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report.Additional Narrative:D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.If information is obtained that was not available for the initial MedWatch, a Follow-up MedWatch will be filed as appropriate.