MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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

Revision tha: in situ: s-rom 20x15x165 36+8 lat stem, 20b lg sleeve, 11/13 taper 28+0 ceramic head, 52mm cup, 52/28mm lipped poly liner.Original surgery "6 years ago" (surgeon quote, no actual date obtained).Revised for thigh pain.Stem replaced with 20x15x225 36+8 lat stem, cup revision 52/32 lipped liner, 32+0 ceramic head.

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 and d6b.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.

Event Description

Affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the attached x-ray images could not confirm the reported complaint.A root cause could not be determined.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 manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: b1 (adverse event), b2.B1 (product problem) should not have been checked since there was no reported device problem.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10819020
• MDR Text Key: 215612025
• Report Number: 1818910-2020-24372
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (y/n): N
• PMA/PMN Number: K910664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 52-3420
• Device Catalogue Number: 523420
• Device Lot Number: 6812019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/26/2020; 01/20/2021
• Supplement Dates FDA Received: 11/30/2020; 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 11/13 28MM +0; PINN MAR LIP LNR 28IDX52OD; PINN SECTOR HA ACET CUP 52MM; S-ROM*SLEEVE PRX ZTT, 20B-LRG; DELTA CER HEAD 11/13 28MM +0; PINN MAR LIP LNR 28IDX52OD; PINN SECTOR HA ACET CUP 52MM; S-ROM*SLEEVE PRX ZTT, 20B-LRG
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR