MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM AMT SZ1 STD OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number 1570-04-070

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2021

Event Type  Injury  

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 Description

It was reported that the patient's left hip was explanted due to infection.Implants are unavailable for return and some part numbers were illegible.It was also indicated that there was loosening of unknown component at the cement to implant interface.Cemented c stem was loose in cement mantle.Doi: unknown; dor: (b)(6) 2021; affected side: left hip.

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 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 device history record (mre) review, was not possible because the required lot code was not provided.H10 additional narrative: updated: h6 (medical device problem code) to capture loss of or failure to bond (a040102) at the cement to implant interface.

• Brand Name: C-STEM AMT SZ1 STD OFFSET
• Type of Device: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12342299
• MDR Text Key: 267264532
• Report Number: 1818910-2021-18174
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295059592
• UDI-Public: 10603295059592
• Combination Product (y/n): N
• PMA/PMN Number: K082239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-04-070
• Device Catalogue Number: 157004070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 36+5MM COCR FEMORAL HEAD; 52MM PINNACLE CUP; ALTRX +4 10D 36IDX52OD; C-STEM AMT SZ1 STD OFFSET; 36+5MM COCR FEMORAL HEAD; 52MM PINNACLE CUP; ALTRX +4 10D 36IDX52OD; C-STEM AMT SZ1 STD OFFSET
• Patient Outcome(s): Required Intervention