MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 45MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Model Number	1363-45-000
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 the depuy sticker was attached directly to the femoral head implant instead of the blue plastic it is supposed to be attached to.Implant was immediately removed from sterile field and a new implant was opened.Surgery time was extended by 2 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Although reportedly taken, no photographic images were provided.The device manufacturing record has been reviewed with no deviations or anomalies found.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary visual examination of the returned device found nothing indicative of a device nonconformance.The investigation cannot confirm the reported allegation with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.Device history review a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.H10 additional narrative: added: a1, a2 (age) and a3 corrected: h3.
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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1 and h3.

• Brand Name: MODULAR CATHCART BALL 45MM OD
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13025953
• Report Number: 1818910-2021-28366
• Device Sequence Number: 1766035
• Product Code: LZY
• UDI-Device Identifier: 10603295032779
• UDI-Public: 10603295032779
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2021

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 Model Number: 1363-45-000
• Device Catalogue Number: 136345000
• Device Lot Number: D19061730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 02/02/2022; 05/23/2022; 07/06/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/02/2022; 05/23/2022; 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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
• Patient Age: 81 YR
• Patient Sex: Female