MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ELITE PLUS OGEE CUP 28/43; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS

Model Number	9653-28-043
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 on (b)(6) 2015, the primary surgery was performed via tha for right side with the stem, cup, head and sleeve in question.Competitor plate was also used in the primary surgery.In 2021, when the patient visited the hospital regularly, the cup and plate was loosened.The stem was not loosened.On (b)(6) 2021, the revision surgery was performed.In the revision, after the head was removed, the surgeon tried to remove the stem, but the stem couldn¿t be removed, and it was left in the patient.The competitor implants were set, and the surgery was completed within 30minutes delay.The surgeon commented that the cold welding occurred between the stem and sleeve and the working space was narrow, and he gave up using the schneider cage due to this reason.No further information is available.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
Event or Problem Description
It was decided that all the implants would be removed in the revision surgery due to infection on (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ELITE PLUS OGEE CUP 28/43
• Common Device Name: MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11680976
• Report Number: 1818910-2021-08144
• Device Sequence Number: 2982467
• Product Code: JDI
• UDI-Device Identifier: 10603295318828
• UDI-Public: 10603295318828
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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): 03/31/2021

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 Model Number: 9653-28-043
• Device Catalogue Number: 965328043
• Device Lot Number: 6425378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 10/12/2021; 05/13/2022
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/08/2021; 10/15/2021; 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2013
• 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: DELTA CER HEAD 9/10 28MM -3; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM 9/10 16X11X130 30; DELTA CER HEAD 9/10 28MM -3; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM 9/10 16X11X130 30
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG