MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	121730500
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
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.A2: patient birth year reported as 1956.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
It was reported that there was a revision of right hip cup in 2023 because of early loosening of cup.The loosening occurred between the metal cup and the bone.The patient was satisfied with the surgical outcome from 2023.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: revision of right hip cup because of early loosening of cup.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment "(b)(4) surgeon answer to pcf - english and (b)(4) surgeon answer to pcf - german".The photographs attached were reviewed, only the labels are shown, they do not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.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 photographs provided are not representative of the reported complaint.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: quantity manufactured: (b)(4) 2) date of manufacture: 05-23-2023 3) any anomalies or deviations identified in dhr: none 4) expiry date: 04/30/2033 5) ifu reference: (b)(4).H11 additional narrative: added: d10 (concomitant).

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23076382
• Report Number: 1818910-2025-16065
• Device Sequence Number: 18641033
• Product Code: LPH
• UDI-Device Identifier: 10603295010159
• UDI-Public: (01)10603295010159(17)330430(10)D23024233
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121730500
• Device Lot Number: D23024233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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: ACTIS COLLARED STD SIZE 5.; ALTRX NEUT 36IDX54OD.; DELTA CER HEAD 12/14 36MM +8.5.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE SECTOR II CUP 54MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male