MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR DYNAMIC LOCK RING 58 OR 70; DURALOC IMPLANT : HIP ACETABULAR AUGMENT

Model Number	1249-58-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/27/2020
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
The surgeon performed a revision due to an infected right hip.The patient had a zimmer stem and head in situ, and a depuy cup and liner (details unknown).In this operation, the enduron liner and duraloc locking ring were removed and replaced by zimmer products.The depuy acetabular cup was not removed.Exact date and surgeon of the original operation is unknown, but the stem and head were revised to zimmer implants in late 2000 following a fracture (exact date unknown).The surgeon was unable to provide further details.
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
Please indicate where the fractured occurred? was it the on the implant or bone? answer: due to the presence of cables around the femur, it appears that the fracture in 2000 was the femoral bone.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : it is reasonable there was no error in the manufacturing, sterile processing or material of this product/lot combination that would be a contributing factor in the reported allegations.A manufacturing records evaluation (mre) was not performed.

• Brand Name: DUR DYNAMIC LOCK RING 58 OR 70
• Common Device Name: DURALOC IMPLANT : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11141040
• Report Number: 1818910-2021-00695
• Device Sequence Number: 3950169
• Product Code: LPH
• UDI-Device Identifier: 10603295019794
• UDI-Public: 10603295019794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1249-58-000
• Device Catalogue Number: 124958000
• Device Lot Number: UX2MV1016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 03/18/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/25/2021; 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (ZIMMER); (ZIMMER); ENDURON 10D 58 OR 70ODX28ID; UNKNOWN HIP ACETABULAR CUP; (ZIMMER); (ZIMMER); ENDURON 10D 58 OR 70ODX28ID; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention