MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16D-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0514
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/01/2021
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
It was reported that on (b)(6) 2010, the patient underwent the tha for left hip with the stem, sleeve, liner and head in question.A cup and 4 screws were used but they were manufactured by other company.On (b)(6) 2021, the revision surgery will be performed because the stem was varus and loosened obviously and the sleeve was loosened, too.In the revision, the ibg (impaction bone grafting) will be performed, and the stem will be replaced.The surgeon wants the cup to be left.The presence or absence of pain in the patient and the mechanism of onset are unknown.The details are unknown.No further information is available.The stem might have been inserted slightly varus, and the alignment of the cup would not be such a problem.Since there was no loosening in the cup, it was left as it was, and the liner was changed from 28 mm to 32 mm in consideration of wear and dislocation resistance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12224933
• Report Number: 1818910-2021-15996
• Device Sequence Number: 12297786
• Product Code: LPH
• UDI-Device Identifier: 10603295175247
• UDI-Public: 10603295175247
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• 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): 07/06/2021

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: 55-0514
• Device Catalogue Number: 550514
• Device Lot Number: 3050307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 09/12/2021
• 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: 9/10 COCR HEAD 28MM +3; PINN MAR ETO LIP LNR 28IDX50OD; S-ROM*SLEEVE PRX ZTT, 16D-LRG; SROM 9/10 16X10X130 36; 9/10 COCR HEAD 28MM +3; PINN MAR ETO LIP LNR 28IDX50OD; S-ROM*SLEEVE PRX ZTT, 16D-LRG; SROM 9/10 16X10X130 36
• Outcome Attributed to Adverse Event: Required Intervention