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

Model Number	52-2032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Discomfort (2330)
Date of Event	02/07/2011
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
Patient was revised to address poly wear and osteolysis.Doi: (b)(6) 2008; dor: (b)(6) 2011; (left side).Update: 12/14/2012 - litigation received 11/14/2012 and alleges patient experienced sciatica, hip and back pain, and general hip discomfort.It is also alleged that said failure included but was not limited to a breakdown and/or damage of the poly liner, resulting in metal-on-metal articulation.It is further alleged patient's surgical findings included a catastrophic poly failure with metal on metal articulation.There is no new information that would change the outcome of the investigation.Patient is a resident of (b)(6).Update ad 1 nov 2018: wpc 2269-2011 has been re-opened under (b)(4) due to receipt of ppf and implant records.Ppf has no allegation reported.The patient name was updated and added the patient date of birth and lawyer.Doi: (b)(6) 2008 ; dor: (b)(6) 2011; (left hip).
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, 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.

• 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
• 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: 12407012
• Report Number: 1818910-2021-19057
• Device Sequence Number: 5260925
• Product Code: JDI
• UDI-Device Identifier: 10603295170822
• UDI-Public: 10603295170822
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2013
• Device Model Number: 52-2032
• Device Catalogue Number: 522032
• Device Lot Number: 2652487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2008
• 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: APEX HOLE ELIM POSITIVE STOP; PINN MAR +4 NEUT 32IDX48OD; PINNACLE 100 ACET CUP 48MM; S-ROM*HEAD FEMORAL COCR 32+0; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM STM ST,36+6L NK,11X16X150; APEX HOLE ELIM POSITIVE STOP; PINN MAR +4 NEUT 32IDX48OD; PINNACLE 100 ACET CUP 48MM; S-ROM*HEAD FEMORAL COCR 32+0; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM STM ST,36+6L NK,11X16X150
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female