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
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/26/2021
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 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.
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 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
• Common Device Name: 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
• Report Number: 1818910-2021-18174
• Device Sequence Number: 4633486
• Product Code: KWA
• UDI-Device Identifier: 10603295059592
• UDI-Public: 10603295059592
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K082239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 1570-04-070
• Device Catalogue Number: 157004070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention