MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121730054
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a scheduled revision surgery because they were not satisfied with there previous surgery.The patient had an initial total hip procedure and underwent a hip revision surgery.Currently patient has a pinnacle gription shell, with screws a liner, and a competitor stem and head.During the revision it was noted that there was a loose acetabular cup.
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.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary the charge nurse from (redacted) hospital reached out to us regarding a scheduled revision which will take place on (redacted date).They indicated that the implants would need to be sent off to be investigated as the patient was not satisfied with their previous surgery.Patient had an initial total hip procedure in (redacted city), no other information was provided.Patient then underwent a hip revision surgery in (redacted city), no other information was provided.Currently patient has a pinnacle gription shell (unknown size), with screws (unknown quantity or lengths), a liner (unknown), and a competitor stem and head.(redacted date) surgeon will be removing the stem and the shell; it is not known what implants will be used.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the pinn multihole w/gription 54mm has signs of what appears to be organic material adhered at the outer fixation surface, nothing indicative of a device nonconformance was identified.With the provided evidence and the absence of chronological support for review, there is no clear indication to confirm that there was a weakening of the bond between the implant and the bone interface.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the pinn multihole w/gription 54mm would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot 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.Corrected: h3.
Event or Problem Description
Additional information received states that the affected side was the left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the charge nurse from (redacted) hospital reached out to us regarding a scheduled revision which will take place on (redacted date).They indicated that the implants would need to be sent off to be investigated as the patient was not satisfied with their previous surgery.Patient had an initial total hip procedure in (redacted city), no other information was provided.Patient then underwent a hip revision surgery in (redacted city), no other information was provided.Currently patient has a pinnacle gription shell (unknown size), with screws (unknown quantity or lengths), a liner (unknown), and a competitor stem and head.(redacted date) surgeon will be removing the stem and the shell, it is not known what implants will be used.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment img_7278.Jpg, img_7276.Jpg, img_7277.Jpg, img_7279.Jpg, img_7281.Jpg, img_7280.Jpg, img_7282.Jpg, img_7283.Jpg, img_7284.Jpg.The photo investigation revealed that the pinn multihole w/gription 54mm was covered of blood remnants.However, with the provided photographs and the absence of chronological evidence for review, there is no clear indication to confirm that there was a weakening of the bond between the implant and the bone interface.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the pinn multihole w/gription 54mm would have not contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 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.Added: b5.

• Brand Name: PINN MULTIHOLE W/GRIPTION 54MM
• 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: 22034719
• Report Number: 1818910-2025-07992
• Device Sequence Number: 18326304
• Product Code: KWA
• UDI-Device Identifier: 10603295009993
• UDI-Public: (01)10603295009993(17)330930(10)M4670U
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121730054
• Device Lot Number: M4670U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 07/07/2025; 07/07/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/22/2025; 07/08/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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: UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN SCREWS-POLY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown