MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 40MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-40-740

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/08/2021

Event Type  Injury  

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 Description

It was reported that the patient had an lps proximal femoral replacement recently and dislocated.A zimmer acetabular cup was already in there so hip was converted to a zimmer constrained liner and head was changed to accommodate sizing.Doi: (b)(6) 2021.Dor: (b)(6) 2021.Affected side: left hip.

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:  a concomitant product was identified to be a competitor product used in conjunction with the previously reported adverse event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Use of this depuy femoral head with competitor manufactured acetabular devices is not recommended and is considered of-label use.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: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: h6 investigation conclusion: appropriate term/code not available (d17) used to capture cause cannot be traced to device (d10).

• Brand Name: DLT TS CER HD 12/14 40MM +12
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12371041
• MDR Text Key: 268256874
• Report Number: 1818910-2021-18744
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033721
• UDI-Public: 10603295033721
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-40-740
• Device Catalogue Number: 136540740
• Device Lot Number: 9319614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DLT TS CER HD 12/14 40MM +12; LPS CEMENTED STEM 12X125MM STR; LPS PROX FEM STD BODY NEUTRAL; LPS SEGMENTAL COMPONENT 30MM; LPS SEGMENTAL COMPONENT 40MM; UNKNOWN HIP ACETABULAR LINERS; ZIMMER ACETABULAR CUP; DLT TS CER HD 12/14 40MM +12; UNKNOWN HIP ACETABULAR LINERS; ZIMMER ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 89