MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision of an acetabular hip pinnacle cup.The surgeon commented that the cup was coming out the back.Surgeon replaced with bimentum dual mobility system and revision head.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6: 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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received: a.I would like to request a confirmation of product code for the femoral head for this case.Surgeon was pretty positive it was properly 32/36 head ¿ most likely the +5 (136522000 articuleze ball 32mm +5/ 136552000 articuleze m head 36mm +5) that was removed from the patient, but there was no way to read off the femoral head as was so worn and scratched.We tried to determine the engagement length off trials we had.However, there was a fair amount of damage during the patient¿s trauma event that led to the revision and damaged the cup, liner and femoral head.But he also mentioned that 20 years ago there was some odd heads about so we couldn't be sure.B.Just for clarification- the reason for this revision ¿ was it due to patient factors?? what was the trauma event? yes, it is reasonable to conclude that the primary reason for revision is driven by patient factors and trauma.I believe it was a little difficult to ascertain the exact timing and events due to the patient not being a reliable historian however it seemed that the patient had two trauma events (he didn't give too much detail around these).Following the first event the surgeon wasn't sure if the patient had sought medical attention and he believed this compounded damage to the cup as there was time between this event and the second.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5, d10 (concomitant).Corrected: e1 (facility name).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN SECTOR W/GRIPTION 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21871817
• Report Number: 1818910-2025-05773
• Device Sequence Number: 8641020
• Product Code: KWA
• UDI-Device Identifier: 10603295010302
• UDI-Public: (01)10603295010302(17)321031(10)M1355G
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: Health Professional
• Device Catalogue Number: 121732052
• Device Lot Number: M1355G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 36IDX52OD.; ARTICUL/EZE CER BALL 36 + 5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female