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

Model Number	55-0513
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
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
The primary surgery was performed on (b)(6) 2008 via tha at another hospital (b)(6).It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the stem (p/n: 900550210), the sleeve (p/n: 550513), the head (p/n: 152190057), the cup (p/n: unknown) and the liner (p/n: unknown) due to suspicion of armd, osteolysis and the loosening of the stem and the cup.During the surgery, it was confirmed that the implants were showed sign of black ring but there was no bone necrosis and soft tissue necrosis.The osteolysis occurred on large area.The revision surgery was completed with no surgical delay.The surgeon requested to investigate the stem¿s junction part (between the stem to neck, sleeve and inner boll).No further information is available.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.Corrected: h6 the previous device code osseointegration issue is being corrected to loss of osseointegration.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 received states that the screws explanted were non-depuy products and the implants had a ring-shaped blackened as stated in the event.
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
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.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).Investigation summary: examination of the returned sleeve component finds nothing outward to suggest a product problem.There is nothing unusual for a device having been is-situ for approximately 12 years.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).A manufacturing records evaluation (mre) was not performed.Corrected: h3.

• 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: 10119691
• Report Number: 1818910-2020-13214
• Device Sequence Number: 3636156
• Product Code: LPH
• UDI-Device Identifier: 10603295175230
• UDI-Public: 10603295175230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: 55-0513
• Device Catalogue Number: 550513
• Device Lot Number: 2439609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 06/18/2020; 06/18/2020; 11/08/2020; 01/25/2021
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/12/2020; 06/19/2020; 06/19/2020; 11/25/2020; 01/26/2021
• 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.; COMPETITOR SCREW.; PINN LINER LIPPED 28IDX50OD.; PINN-A MULTIHOLE ACET CUP 50MM.; S-ROM*SLEEVE PRX ZTT, 16D-SML.; SROM 9/10 16X11X130 30+4.; 9/10 COCR HEAD 28MM -3; PINN LINER LIPPED 28IDX50OD; PINN-A MULTIHOLE ACET CUP 50MM; S-ROM*SLEEVE PRX ZTT, 16D-SML; SROM 9/10 16X11X130 30+4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50