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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 32+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 32+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 52-2032
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Fall (1848); Joint Dislocation (2374)
Date of Event 02/01/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The primary surgery was performed via tha at another hospital ((b)(6) hospital).The date of the primary surgery was unknown.The used implants were, the cup and the liner were manufactured by zimmer biomet, the stem was depuy's product (srom series).It was reported that the patient fell and had dislocation.On (b)(6) 2021, the patient underwent the revision surgery.In the revision, the surgeon found that the locking ring of the liner had came off and dislocated.The cup and stem were not loosened.The surgeon replaced the liner and head with the new one and the surgery was completed successfully.The revision surgical time is about 90 minutes.
 
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.
 
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Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key11398493
Report Number1818910-2021-04101
Device Sequence Number14233309
Product Code JDI
UDI-Device Identifier10603295170822
UDI-Public10603295170822
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K920317
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
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
Report Date (Section B) 02/16/2021
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 Number52-2032
Device Catalogue Number522032
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/16/2021
Supplement Date Received by Manufacturer04/29/2021
Initial Report FDA Received Date03/02/2021
Supplement Report FDA Received Date04/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SROM STEM; UNKNOWN HIP FEMORAL HEAD; ZIMMER BIOMET CUP; ZIMMER BIOMET LINER; SROM STEM; UNKNOWN HIP FEMORAL HEAD; ZIMMER BIOMET CUP; ZIMMER BIOMET LINER
Outcome Attributed to Adverse Event Required Intervention;
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