MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM DISTAL TAPERED 17X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1976-17-140
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported that the plastic cover that goes over the reclaim stem taper has had to be chiselled and cut off during this procedure.It clearly says on the item to ¿remove after reaming¿ but despite an experienced scrub member suggesting we removed it, the surgeon who is fairly new to the procedure, as am i, refused to take it off as it clearly stated to leave it on.Having reamed over this using the 20mm prox drill, they were struggling to sink it far enough, due to the plastic, so attempted to remove it, but it wouldn¿t budge.We had no spare stem, and were actually unable to reverse the stem as it was stuck in so well.Luckily after 20 minutes of trying we were able to cut it off, but the surgeons were 2 minutes away from converting to an eto in order to remove the whole stem which would have had a massive implication on the patients recovery.Fortunately the only outcome was an extended length of surgery, for which nothing happened to the patient while on the table but we are unable to quantify the effects long-term.Having spoken to a colleague after the procedure, i was told these implants were old and not all had the taper cover on them.My thought, and the surgeons also, is that those implants should be completely removed from the system, while the writing on them so clearly says to leave it on.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.Review of the photographic evidence revealed that the taper protector sleeve has been cut off from the stem, because it could not be removed.Therefore the allegation can be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Brand Name: RECLAIM DISTAL TAPERED 17X140
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 15638158
• Report Number: 1818910-2022-20930
• Device Sequence Number: 5868032
• Product Code: LZO
• UDI-Device Identifier: 10603295077053
• UDI-Public: 10603295077053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 10/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1976-17-140
• Device Catalogue Number: 197617140
• Device Lot Number: 534850
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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-2084-2014
• Patient Sequence Number: 1
• Patient Sex: Unknown