MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 20X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-20-190
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision of a c-stem.Female.Left side.The reason for revision was due to a periprosthetic fracture.Patient had a fall.The c-stem and head were removed, and reclaim was implanted.Duraloc cup and liner were left in situ.Stryker (dall-miles) cables were used for closure of proximal bone.It was also challenging to remove the poly taper protector from the reclaim stem 1977-20-190 lot 651324.This added a 5min delay to remove.The patient had a revision on (b)(6) 2022 where the charnley elite stem, head, and duraloc liner were removed.The reason for this revision was due to poly wear which had caused the stem to loosen, and caused significant bone loss.A c-stem was implanted, and poly was replaced with a marathon poly.Stryker cables (dall-miles) were also used.
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 : a manufacturing record evaluation was performed for the finished device 197720190, lot 651324, and no non-conformances / manufacturing irregularities were identified.
Event or Problem Description
Additional information received indicated that the patient had a fall which caused the periprosthetic fracture and the need for revision.
Additional Manufacturer Narrative
Product complaint # = > pc-(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, d4 (expiration date), d6b if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d10.

• Brand Name: RECLAIM DISTAL TAPERED 20X190A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16213849
• Report Number: 1818910-2023-01576
• Device Sequence Number: 14566444
• Product Code: LZO
• UDI-Device Identifier: 10603295077275
• UDI-Public: 10603295077275
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2023

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 Expiration Date: 03/31/2025
• Device Model Number: 1977-20-190
• Device Catalogue Number: 197720190
• Device Lot Number: 651324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2023
• Supplement Date Received by Manufacturer: 02/01/2023; 03/27/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/09/2023; 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2083-2014
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C-STEM AMT SZ1 STD OFFSET; C-STEM AMT SZ1 STD OFFSET; COMPETITOR PRODUCT; COMPETITOR PRODUCT; COMPETITOR PRODUCT; DELTA CER HEAD 12/14 28MM +5; DELTA CER HEAD 12/14 28MM +5; DELTA CER HEAD 12/14 28MM +5; DUR MAR NEUT LINER 28IDX48OD; DUR MAR NEUT LINER 28IDX48OD; RECLAIM DISTAL TAPERED 20X190A; RECLAIM PRX BDY CONE 20X85; RECLAIM PRX BDY CONE 20X85; STRYKER (DALL-MILES) CABLE; STRYKER (DALL-MILES) CABLE; STRYKER (DALL-MILES) CABLE; STRYKER (DALL-MILES) CABLE; STRYKER (DALL-MILES) CABLE; STRYKER (DALL-MILES) CABLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female