PINNACLE GRIPTION
Received Jul 29, 2026 · Event occurred Jul 8, 2026
Report 1818910-2026-12903 · MDR key 50068816
Device
Generic name
Pinnacle Hip System : Hip Metal Acetabular Cups
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
121732058
Lot number
4056713
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Pain
Narrative
Description of Event or Problem
It was reported that patient was revised due to pain.Affected Side: Right.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (b)(4)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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11. Additional Manufacturer Narrative:H3, H6:There is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s). A Manufacturing Records Evaluation (MRE) was not performed.No device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s). A Records Evaluation (MRE) was not perform.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.