MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 45X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103545000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bipolar cup implant had a loose liner.Product was unable to be used properly.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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.
Event or Problem Description
Additional information received states that the implant product white liner was loose and does not fit nicely in the metal cup.The cup is unfit for patient use.
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 = > bipolar cup implant had a loose liner.Product was unable to be used properly.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the polyethene insert and collar components were returned assembled, however the insert-collar assembly was received separated from the metal shell component.There were no signs of damage or defects with any of the components.However, it is worth mentioning that the gap in the collar appeared to be smaller than normal.Additional information from the hospital informed customer quality that they decontaminated the product together with other sterile instruments.This information confirms the possibility that the insert may have inadvertently been exposed to high temperatures prior to the observations made in the complaint.However, without further confirmation of this part entering decontamination prior to the event, no further conclusion can be drawn at this time a manufacturing record evaluation was performed for the finished device product description: self cent hip 45x28 gry product code: 103545000 lot number: m5354a and no non-conformances or manufacturing irregularities were identified.A dimensional inspection was performed and confirms that the device was out of specifications as the gap in the collar is smaller, most likely due to the integrity of the poly components was compromised by the exposure to an environment of high temperatures.The overall complaint was confirmed as the undersized condition of the insert and collar components would have contribute to the reported loose self cent hip 45x28 gry.However, without further confirmation of this part entering decontamination prior to the event; the potential cause could not be established.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.Drawing/specifications reviewed? dwg - 103502002 rev j.Current and manufactured.Dimensional inspection: specified dimension gap in the collar= 3.97 + 0.75 / - 0.00 mm measured dimension: gap in the collar= 2.46 mm (not complies) device used: digimatic caliper cd78619 device history lot = > a manufacturing record evaluation was performed for the finished device product description: self cent hip 45x28 gry product code: 103545000 lot number: m5354a and no non-conformances or manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device product description: self cent hip 45x28 gry product code: 103545000 lot number: m5354a and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: SELF CENT HIP 45X28 GRY
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20469757
• Report Number: 1818910-2024-21751
• Device Sequence Number: 7472156
• Product Code: KWY
• UDI-Device Identifier: 10603295003359
• UDI-Public: (01)10603295003359(17)281231(10)M5354A
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K812672
• 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
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 103545000
• Device Lot Number: M5354A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 11/18/2024; 02/21/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 10/30/2024; 11/21/2024; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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 CUP.
• Patient Sex: Unknown