MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM AMT SZ4 STD OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	1570-04-100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Linked pc was created (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
Total hip replacement revision due to posterior dislocation.Previous revision of primary liner to constrained liner was on (b)(6) 2021.Entire construct, including femur, was revised as when the head was removed the stem came out at the same time.Reason for revision was recurrent dislocation.
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.
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.H10 additional narrative: added: b5.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
Additional information was received indicating that "a.Was there stem loosening? "not pre-op." b.Was there a surgical delay because of this event? if yes, what was the duration of the delay? no delay.C.Please give reason why the cup was revised? was there indication that it was malposition, loose or etc.? "malposition of the cup was reason for revision of the cup".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this complaint was received for examination.The photo investigation cannot confirm the reported allegation with the provided information.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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).A manufacturing records evaluation (mrae) was not performed.

• Brand Name: C-STEM AMT SZ4 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13768971
• Report Number: 1818910-2022-04639
• Device Sequence Number: 11753896
• Product Code: JDI
• UDI-Device Identifier: 10603295059639
• UDI-Public: 10603295059639
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-04-100
• Device Catalogue Number: 157004100
• Device Lot Number: D11100530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 03/29/2022; 04/26/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 03/18/2022; 04/04/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2011
• 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: DLT TS CER HD 12/14 32MM +1; PINN LNR CON +4 NEUT 32IDX60OD; PINNACLE SECTOR II CUP 60MM
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 80 KG